ClinicalTrials.gg
Sign In
RecruitingNCT05938465PROFUpdated May 28, 2026

Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)

A Phase 1/2 interventional study of EXE-346 and Placebo in Ileal Pouch, sponsored by Exegi Pharma, LLC. Recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Exegi Pharma, LLC · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2023; still recruiting 3 years later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to assess the safety and preliminary efficacy of treatment with EXE-346, a live biotherapeutic, which may reduce bowel movement frequency in patients with an ileal pouch-anal anastomosis (IPAA) and lead to a higher quality of life.

Read the detailed description

The aim of this study is to assess the safety and preliminary efficacy of treatment with EXE-346 which may reduce bowel movement frequency in patients with an IPAA and lead to a higher quality of life. EXE-346 is a live biotherapeutic product containing a fixed proportion mixture of 8 individual bacterial strains.

The Phase 1b part of the study is an open label (OL), single-arm study to assess the safety of EXE-346 administered orally for up to 4 weeks.

The Phase 2 part of the study is a randomized, double-blinded study to assess the safety and efficacy of the same dose of EXE-346 administered orally for up to 8 weeks, compared with placebo. Subjects who complete the Phase 2 double-blinded part of the study will be eligible to participate in an optional open label extension phase to receive EXE-346 for up to 8 weeks.

02

Conditions studied

  • Ileal Pouch

Browse trials for

Keywords

  • Pouchitis
  • Pouch
  • Ileal Pouch Anastomosis
  • IPAA
03

In context

Pouchitis

50 studies on the registry are indexed under Pouchitis; 12 are open to participants now.

This study's planned enrollment of 50 is above the median of 20 across 42 interventional studies indexed under Pouchitis.

Browse Pouchitis studies →

Lead sponsor

This is the only study on the registry with Exegi Pharma, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject is a male or female and is between the age of 18 to 70 years, inclusive, at screening.
  2. Subject has had a documented pouchoscopy within 12 months prior to screening.
  3. Subject or the subject's legally authorized representative is willing and able to provide written prior to the initiation of any study-related procedures.
  4. Subject has an average daily bowel movement frequency of at least 10 bowel movements recorded during screening and has correctly completed at least 7 days of eDiary entries during the screening period (Days -13 to 0).

Inclusion Criteria - Phase 2 Double-Blinded Part Only

  1. Subject is a male or female and is aged 18 years or older at screening.
  2. Subject is willing and able to provide written informed consent prior to the initiation of any study-related procedures.
  3. Subject has an average daily bowel movement frequency of at least 10 bowel movements recorded during screening and has correctly completed at least 7 days of eDiary entries during the screening period (Days -21 to 0).

Inclusion Criteria - Both Phase 1b and Phase 2 Double-Blinded Parts

  1. Subject has had an IPAA for at least 6 months prior to screening.
  2. Female subjects of must have a negative serum pregnancy test result at screening and must not be lactating and/or breastfeeding.
  3. Subjects (female subjects of childbearing potential and male subjects with partners of childbearing potential) must agree to use proper methods (see Section 13.2 for contraceptive guidance) to avoid pregnancy during the study. Nonchildbearing potential is defined as at least 6 weeks after a hysterectomy with or without surgical bilateral oophorectomy or (at least 12 months since natural amenorrhea).

Inclusion Criteria - Optional Open-Label Extension Phase Only

  1. Subjects must have completed the Phase 2 double-blinded part of the study and are willing to participate in the optional open-label extension phase.

    Note: Subjects who discontinued study treatment in the Phase 2 double-blinded part but who have remained in the study for safety monitoring are eligible for continued safety monitoring in the optional open-label extension phase; however, study treatment will not be re-started in such subjects.

  2. Subjects must understand the study procedures, the risks involved, and are willing to continue to adhere to the study visit/protocol schedule.

Exclusion Criteria Subjects meeting any of the criteria specified below for the study phase in which they are enrolling will be excluded from the study.

Exclusion criteria

Exclusion Criteria - Phase 1b Only

  1. Subject has Crohn's-like disease of the pouch, as indicated by their most recent pouchoscopy during the 12 months prior to screening.
  2. Subject has a stricture of the IPAA or afferent limb stricture, as indicated by their most recent pouchoscopy during the 12 months prior to screening.
  3. Subject has taken biologics, azathioprine, or methotrexate within the 12 weeks prior to screening or systemic within 4 weeks of screening.
  4. Subject has a positive reverse transcriptase-PCR diagnostic test for SARS-CoV-2 within the 14 days prior to screening.
  5. Subject has uncontrolled hypertension (systolic pressure >160 mm Hg or diastolic pressure >95 mm Hg on at least 2 measures performed at least 10 minutes apart) at screening.

Exclusion Criteria - Phase 2 Double Blinded Part Only

  1. Subject has Crohn's-like disease of the pouch, as indicated by the pouchoscopy conducted during study screening.
  2. Subject has isolated severe cuffitis without pouch inflammation (endoscopic mPDAI score of 2 or lower), as indicated by the pouchoscopy conducted during study screening.
  3. Subject has a stricture of the IPAA or afferent limb stricture which requires surgery or recurrent dilations more than every 3 months, as indicated by the pouchoscopy conducted during study screening. Subjects who have a planned dilation during the active study period are excluded (dilation during the screening pouchoscopy is allowed).
  4. Subject has taken biologics, azathioprine, methotrexate or small molecules (e.g., JAK inhibitors, S1P receptor modulators) within the 12 weeks prior to screening or systemic steroids within 4 weeks prior to screening.
  5. Subject has a positive reverse transcriptase-PCR diagnostic test for SARS-CoV-2 within the 7 days prior to screening, per subject self report.
  6. Subject has an average daily bowel movement frequency of >25 bowel movements recorded during the screening period (Days -21 to 0).
  7. Subject is taking opioid therapy as a long-term treatment or has taken opioids within 2 weeks prior to screening.
  8. Subject has taken probiotics within 2 weeks prior to screening.
  9. Subject has previously received EXE-346 for any duration. Subjects who participated in Phase 1b are excluded from Phase 2.
  10. Subject has a concurrent, clinically significant, serious, unstable or uncontrolled medical or psychiatric condition that, in the opinion of the investigator, might confound study results, pose additional risk to the subject, or interfere with the subject's ability to participate fully in the study.

Exclusion Criteria - Both Phase 1b and Phase 2 Double-Blinded Part

  1. Subject has enterocutaneous or recto- or pouch-vaginal fistula.
  2. Subject has active Clostridium difficile infection.
  3. Subject has known or suspected active CMV infection.
  4. Subject initiated a new treatment with antibiotics or antimotility therapies within the 2 weeks prior to screening or plans to start a new or change doses of a current treatment during the study period (screening visit through the safety follow-up visit [Day 57 in the Phase 1b part or Day 71 in the Phase 2 part]). Subjects taking antibiotics to treat antibiotic-dependent pouchitis or antidiarrheal medication are eligible for the study provided they have been on the therapy at a stable dose for at least 2 weeks prior to screening.
  5. Subject is taking NSAIDs as a long-term treatment (ie, consistent use for at least 4 days/week each month). Acute use of NSAIDs is allowed.
  6. Subject has a known history or positive test during screening for , HIV-1, HIV-2, or active or . Active HCV infection is defined as a subject with a positive hepatitis C antibody and detectable hepatitis C viral load RNA.
  7. Subject has a history of within the 5 years prior to screening, with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia, or treated in situ grade 1 cervical cancer.
  8. Subject has estimated \<30 mL/min/1.73 m2 at screening.
  9. Subject has known to EXE-346 or any product components.
  10. Female subject is pregnant or lactating and/or breastfeeding.
  11. Subject has participated in any clinical study of an approved or nonapproved medicinal product within the 30 days prior to screening.

  12. Subject has any disorder that, in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol, including but not limited to:

    1. Decompensated liver disease
    2. Elevation of , ALT, or >2 ×
    3. Primary sclerosing cholangitis with elevated transaminases

Exclusion Criteria - Optional Open-Label Extension Phase Only

1. Subjects who have developed any medical or psychologic condition, which was excluded in the Phase 2 double-blinded part of the study or in the opinion of the investigator and/or medical monitor might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.

Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Phase 1b Open Label

    EXE-346 live biotherapeutic product, 1500x10\^9 colony forming units (CFU) twice daily (BID), 4 weeks

    Biological: EXE-346

  • Experimental
    Phase 2: Active Arm

    EXE-346 live biotherapeutic product, 1500x10\^9 CFU BID, 8 weeks

    Biological: EXE-346

  • Placebo comparator
    Phase 2: Placebo Arm

    Powder containing same inactive ingredients as EXE-346 but none of the active ingredients, BID, 8 weeks

    Other: Placebo

  • Experimental
    Phase 2 Open Label Extension (optional)

    EXE-346 live biotherapeutic product, 1500x10\^9 CFU BID, 8 weeks

    Biological: EXE-346

Interventions

  • BiologicalEXE-346

    EXE-346 contains a proprietary, fixed-dose, lyophilized blend of 8 strains of gram positive, lactic acid bacteria. EXE-346 excipients are maltose and silicon dioxide.

  • OtherPlacebo

    Placebo contains excipients maltose and silicon dioxide.

06

What researchers measure

Primary outcomes

  1. Phase 1b: Incidence, Severity, Relatedness, and Frequency of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)

    To assess the safety of EXE-346 using incidence, severity, relationship to study treatment, and frequency of treatment emergent adverse events (TEAE) and serious adverse events (SAE).

    Time frame: 4 weeks

  2. Phase 1b: Number of Participants with Abnormal Physical Examinations

    To assess the safety of EXE-346 using abnormal findings in physical examinations after the start of study treatment that suggest a clinically significant worsening of medical issue.

    Time frame: 4 weeks

  3. Phase 1b: Number of Participants with Abnormal Vital Signs

    To assess the safety of EXE-346 using abnormal findings in vital sign readings after the start of study treatment that suggest a clinically significant worsening of medical issue, including blood pressure.

    Time frame: 4 weeks

  4. Phase 1b: Number of Participants with Abnormal Safety Labs

    To assess the safety of EXE-346 using markedly abnormal findings in safety labs after the start of study treatment that suggest a clinically significant worsening of medical issue.

    Time frame: 4 weeks

  5. Phase 1b: Study Treatment Discontinuation Due to Treatment Emergent Adverse Events (TEAEs)

    To assess the safety of EXE-346 using study treatment discontinuation due to TEAE(s).

    Time frame: 4 weeks

  6. Phase 2: Incidence, Severity, Relatedness, and Frequency of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)

    To assess the safety of EXE-346 using incidence, severity, relationship to study treatment, and frequency of TEAEs and SAEs.

    Time frame: 8 weeks

  7. Phase 2: Number of Participants with Abnormal Physical Examinations

    To assess the safety of EXE-346 using abnormal findings in physical examinations after the start of study treatment that suggest a clinically significant worsening of medical issue.

    Time frame: 8 weeks

  8. Phase 2: Number of Participants with Abnormal Vital Signs

    To assess the safety of EXE-346 using abnormal findings in vital sign readings after the start of study treatment that suggest a clinically significant worsening of medical issue, including blood pressure.

    Time frame: 8 weeks

  9. Phase 2: Number of Participants with Abnormal Safety Labs

    To assess the safety of EXE-346 using markedly abnormal findings in safety labs after the start of study treatment that suggest a clinically significant worsening of medical issue.

    Time frame: 8 weeks

  10. Phase 2: Study Treatment Discontinuation Due to Treatment Emergent Adverse Events (TEAEs)

    To assess the safety of EXE-346 using study treatment discontinuation due to TEAE(s).

    Time frame: 8 weeks

  11. Phase 2: Change in Total Daily Bowel Movement Frequency

    To assess the efficacy of EXE-346 to reduce the total daily bowel movement frequency using change in average daily bowel movement frequency from baseline to each post-baseline week

    Time frame: 8 weeks

  12. Phase 2 Open Label: Incidence, Severity, Relatedness, and Frequency of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)

    To assess the safety of EXE-346 using incidence, severity, relationship to study treatment, and frequency of TEAEs and SAEs.

    Time frame: 8 weeks

  13. Phase 2 Open Label: Number of Participants with Abnormal Physical Examinations

    To assess the safety of EXE-346 using abnormal findings in physical examinations after the start of study treatment that suggest a clinically significant worsening of medical issue.

    Time frame: 8 weeks

  14. Phase 2 Open Label: Number of Participants with Abnormal Vital Signs

    To assess the safety of EXE-346 using abnormal findings in vital sign readings after the start of study treatment that suggest a clinically significant worsening of medical issue, including blood pressure.

    Time frame: 8 weeks

  15. Phase 2 Open Label: Number of Participants with Abnormal Safety Labs

    To assess the safety of EXE-346 using markedly abnormal findings in safety labs after the start of study treatment that suggest a clinically significant worsening of medical issue.

    Time frame: 8 weeks

  16. Phase 2 Open Label: Study Treatment Discontinuation Due to Treatment Emergent Adverse Events (TEAEs)

    To assess the safety of EXE-346 using study treatment discontinuation due to TEAE(s).

    Time frame: 8 weeks

Secondary outcomes

  1. Phase 1b: Bowel Movement Frequency

    To assess the effect of EXE-346 on bowel movement frequency using change in average daily bowel movement frequency from baseline to each post-baseline week

    Time frame: 4 weeks

  2. Phase 1b: Nighttime Awakening Frequency

    To assess the effect of EXE-346 on nighttime awakening frequency using change in average nighttime awakenings for bowel movements from baseline to each post-baseline week

    Time frame: 4 weeks

  3. Phase 1b: Bowel Movement Consistency

    To assess the effect of EXE-346 on bowel movement consistency using change in average consistency of daily bowel movements from baseline to each post-baseline week

    Time frame: 4 weeks

  4. Phase 2: Nighttime Awakening Frequency

    To assess the effect of EXE 346 on nighttime awakening frequency using change in average nighttime awakenings for bowel movements from baseline to each post-baseline week

    Time frame: 8 weeks

  5. Phase 2: Bowel Movement Consistency

    To assess the effect of EXE-346 on bowel movement consistency using change in average consistency of daily bowel movements from baseline to each post-baseline week

    Time frame: 8 weeks

Other outcomes

  1. Phase 1b: Change in Fecal Calprotectin Level

    To evaluate the effect of EXE-346 on fecal calprotectin levels after 4 weeks. The change from baseline fecal calprotectin level will be evaluated at Day 15 and Day 29.

    Time frame: 4 weeks

  2. Phase 2: Change in mPDAI Score

    To evaluate the effect of EXE-346 on the mPDAI total score from baseline to day 57.

    Time frame: 8 weeks

  3. Phase 2: Change in Clinical Subscore of mPDAI

    To evaluate the effect of EXE-346 on the mPDAI clinical subscores after 8 weeks. Change from baseline clinical subscores will be calculated at Day 15, Day 29, and Day 57.

    Time frame: 8 weeks

  4. Phase 2: Change in Endoscopic Subscore of mPDAI

    To evaluate the effect of EXE-346 on the mPDAI endoscopic subscore from baseline to day 57.

    Time frame: 8 weeks

  5. Phase 2: Change in EPS

    To evaluate the effect of EXE-346 on EPS after 8 weeks.

    Time frame: 8 weeks

  6. Phase 2: Change in Fecal Calprotectin Level

    To evaluate the effect of EXE-346 on fecal calprotectin levels after 8 weeks. The change from baseline fecal calprotectin level will be evaluated at Day 15, Day 29, and Day 57.

    Time frame: 8 weeks

  7. Phase 2: Change in SF-36 Score

    To evaluate the effect of EXE-346 on patient reported outcomes after 8 weeks. Change in 36 items Short Form Survey Instrument (SF-36) score from baseline will be calculated at Day 29 and Day 57.

    Time frame: 8 weeks

  8. Phase 2: Change in GI PROMIS Score

    To evaluate the effect of EXE-346 on patient reported outcomes after 8 weeks. Change in Gastrointestinal Patient Reported Outcomes Measurement Information System (GI PROMIS) score from baseline will be calculated at Day 29 and Day 57.

    Time frame: 8 weeks

  9. Phase 2: Percentage of Subjects Initiating Prohibited Medications

    To assess the effect of EXE-346 on use of prohibited medications. Percentage of subjects who have initiated prohibited medication will be calculated at each study visit.

    Time frame: 8 weeks

  10. Phase 2 Open Label: Bowel Movement Frequency

    To assess the effect of EXE-346 on bowel movement frequency using change in average daily bowel movement frequency from baseline and open-label baseline (baseline-OL) to each post-baseline week.

    Time frame: 8 weeks

  11. Phase 2 Open Label: Nighttime Awakening Frequency

    To assess the effect of EXE-346 on nighttime awakening frequency using change in average nighttime awakening frequency from baseline and open-label baseline (baseline-OL) to each post-baseline week.

    Time frame: 8 weeks

  12. Phase 2 Open Label: Bowel Movement Consistency

    To assess the effect of EXE-346 on bowel movement consistency using change in average consistency of daily bowel movements from baseline and open-label baseline (baseline-OL) to each post-baseline week

    Time frame: 8 weeks

  13. Phase 2 Open Label: Change in mPDAI Clinical Subscores

    To evaluate the effect of EXE-346 on the mPDAI clinical subscores after 8 weeks. Change in clinical subscores will be from baseline and open-label baseline (baseline-OL) to each post-baseline visit.

    Time frame: 8 weeks

  14. Phase 2 Open Label: Change in Fecal Calprotectin

    To evaluate the effect of EXE-346 on fecal calprotectin levels. The change in fecal calprotectin will be calculated from baseline and open-label baseline (baseline-OL) to each post-baseline visit.

    Time frame: 8 weeks

07

Study locations

8 of 8 sites recruiting
08

References and documents

Publications

  • Allison J, Herrinton LJ, Liu L, Yu J, Lowder J. Natural history of severe ulcerative colitis in a community-based health plan. Clin Gastroenterol Hepatol. 2008 Sep;6(9):999-1003. doi: 10.1016/j.cgh.2008.05.022. PubMed 18774533 ↗
  • Barnes EL, Herfarth HH, Sandler RS, Chen W, Jaeger E, Nguyen VM, Robb AR, Kappelman MD, Martin CF, Long MD. Pouch-Related Symptoms and Quality of Life in Patients with Ileal Pouch-Anal Anastomosis. Inflamm Bowel Dis. 2017 Jul;23(7):1218-1224. doi: 10.1097/MIB.0000000000001119. PubMed 28426474 ↗
  • Biancone L, Michetti P, Travis S, Escher JC, Moser G, Forbes A, Hoffmann JC, Dignass A, Gionchetti P, Jantschek G, Kiesslich R, Kolacek S, Mitchell R, Panes J, Soderholm J, Vucelic B, Stange E; European Crohn's and Colitis Organisation (ECCO). European evidence-based Consensus on the management of ulcerative colitis: Special situations. J Crohns Colitis. 2008 Mar;2(1):63-92. doi: 10.1016/j.crohns.2007.12.001. Epub 2008 Jan 28. No abstract available. PubMed 21172196 ↗
  • Bibiloni R, Fedorak RN, Tannock GW, Madsen KL, Gionchetti P, Campieri M, De Simone C, Sartor RB. VSL#3 probiotic-mixture induces remission in patients with active ulcerative colitis. Am J Gastroenterol. 2005 Jul;100(7):1539-46. doi: 10.1111/j.1572-0241.2005.41794.x. PubMed 15984978 ↗
  • Bischoff SC, Escher J, Hebuterne X, Klek S, Krznaric Z, Schneider S, Shamir R, Stardelova K, Wierdsma N, Wiskin AE, Forbes A. ESPEN practical guideline: Clinical Nutrition in inflammatory bowel disease. Clin Nutr. 2020 Mar;39(3):632-653. doi: 10.1016/j.clnu.2019.11.002. Epub 2020 Jan 13. PubMed 32029281 ↗
  • Devaraj B, Kaiser AM. Surgical management of ulcerative colitis in the era of biologicals. Inflamm Bowel Dis. 2015 Jan;21(1):208-20. doi: 10.1097/MIB.0000000000000178. PubMed 25222665 ↗
  • Farouk R, Pemberton JH, Wolff BG, Dozois RR, Browning S, Larson D. Functional outcomes after ileal pouch-anal anastomosis for chronic ulcerative colitis. Ann Surg. 2000 Jun;231(6):919-26. doi: 10.1097/00000658-200006000-00017. PubMed 10816636 ↗
  • Gionchetti P, Calafiore A, Riso D, Liguori G, Calabrese C, Vitali G, Laureti S, Poggioli G, Campieri M, Rizzello F. The role of antibiotics and probiotics in pouchitis. Ann Gastroenterol. 2012;25(2):100-105. PubMed 24714229 ↗
  • Gionchetti P, Rizzello F, Helwig U, Venturi A, Lammers KM, Brigidi P, Vitali B, Poggioli G, Miglioli M, Campieri M. Prophylaxis of pouchitis onset with probiotic therapy: a double-blind, placebo-controlled trial. Gastroenterology. 2003 May;124(5):1202-9. doi: 10.1016/s0016-5085(03)00171-9. PubMed 12730861 ↗
  • Gionchetti P, Rizzello F, Morselli C, Poggioli G, Tambasco R, Calabrese C, Brigidi P, Vitali B, Straforini G, Campieri M. High-dose probiotics for the treatment of active pouchitis. Dis Colon Rectum. 2007 Dec;50(12):2075-82; discussion 2082-4. doi: 10.1007/s10350-007-9068-4. Epub 2007 Oct 13. PubMed 17934776 ↗
  • Gionchetti P, Rizzello F, Venturi A, Brigidi P, Matteuzzi D, Bazzocchi G, Poggioli G, Miglioli M, Campieri M. Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: a double-blind, placebo-controlled trial. Gastroenterology. 2000 Aug;119(2):305-9. doi: 10.1053/gast.2000.9370. PubMed 10930365 ↗
  • Gower-Rousseau C, Dauchet L, Vernier-Massouille G, Tilloy E, Brazier F, Merle V, Dupas JL, Savoye G, Balde M, Marti R, Lerebours E, Cortot A, Salomez JL, Turck D, Colombel JF. The natural history of pediatric ulcerative colitis: a population-based cohort study. Am J Gastroenterol. 2009 Aug;104(8):2080-8. doi: 10.1038/ajg.2009.177. Epub 2009 May 12. PubMed 19436273 ↗
  • Hahnloser D, Pemberton JH, Wolff BG, Larson DR, Crownhart BS, Dozois RR. Results at up to 20 years after ileal pouch-anal anastomosis for chronic ulcerative colitis. Br J Surg. 2007 Mar;94(3):333-40. doi: 10.1002/bjs.5464. PubMed 17225210 ↗
  • Herrinton LJ, Liu L, Lewis JD, Griffin PM, Allison J. Incidence and prevalence of inflammatory bowel disease in a Northern California managed care organization, 1996-2002. Am J Gastroenterol. 2008 Aug;103(8):1998-2006. doi: 10.1111/j.1572-0241.2008.01960.x. PubMed 18796097 ↗
  • Hoffmann JC, Zeitz M, Bischoff SC, Brambs HJ, Bruch HP, Buhr HJ, Dignass A, Fischer I, Fleig W, Folsch UR, Herrlinger K, Hohne W, Jantschek G, Kaltz B, Keller KM, Knebel U, Kroesen AJ, Kruis W, Matthes H, Moser G, Mundt S, Pox C, Reinshagen M, Reissmann A, Riemann J, Rogler G, Schmiegel W, Scholmerich J, Schreiber S, Schwandner O, Selbmann HK, Stange EF, Utzig M, Wittekind C. [Diagnosis and therapy of ulcerative colitis: results of an evidence based consensus conference by the German society of Digestive and Metabolic Diseases and the competence network on inflammatory bowel disease]. Z Gastroenterol. 2004 Sep;42(9):979-83. doi: 10.1055/s-2004-813510. No abstract available. German. PubMed 15455267 ↗
  • Hurst RD, Molinari M, Chung TP, Rubin M, Michelassi F. Prospective study of the incidence, timing and treatment of pouchitis in 104 consecutive patients after restorative proctocolectomy. Arch Surg. 1996 May;131(5):497-500; discussion 501-2. doi: 10.1001/archsurg.1996.01430170043007. PubMed 8624195 ↗
  • Kappelman MD, Rifas-Shiman SL, Kleinman K, Ollendorf D, Bousvaros A, Grand RJ, Finkelstein JA. The prevalence and geographic distribution of Crohn's disease and ulcerative colitis in the United States. Clin Gastroenterol Hepatol. 2007 Dec;5(12):1424-9. doi: 10.1016/j.cgh.2007.07.012. Epub 2007 Sep 29. PubMed 17904915 ↗
  • Kmiot WA, Hesslewood SR, Smith N, Thompson H, Harding LK, Keighley MR. Evaluation of the inflammatory infiltrate in pouchitis with 111In-labeled granulocytes. Gastroenterology. 1993 Apr;104(4):981-8. doi: 10.1016/0016-5085(93)90264-d. PubMed 8462824 ↗
  • Langholz E, Munkholm P, Davidsen M, Binder V. Course of ulcerative colitis: analysis of changes in disease activity over years. Gastroenterology. 1994 Jul;107(1):3-11. doi: 10.1016/0016-5085(94)90054-x. PubMed 8020674 ↗
  • Loftus CG, Loftus EV Jr, Harmsen WS, Zinsmeister AR, Tremaine WJ, Melton LJ 3rd, Sandborn WJ. Update on the incidence and prevalence of Crohn's disease and ulcerative colitis in Olmsted County, Minnesota, 1940-2000. Inflamm Bowel Dis. 2007 Mar;13(3):254-61. doi: 10.1002/ibd.20029. PubMed 17206702 ↗
  • Madiba TE, Bartolo DC. Pouchitis following restorative proctocolectomy for ulcerative colitis: incidence and therapeutic outcome. J R Coll Surg Edinb. 2001 Dec;46(6):334-7. PubMed 11768572 ↗
  • Michelassi F, Lee J, Rubin M, Fichera A, Kasza K, Karrison T, Hurst RD. Long-term functional results after ileal pouch anal restorative proctocolectomy for ulcerative colitis: a prospective observational study. Ann Surg. 2003 Sep;238(3):433-41; discussion 442-5. doi: 10.1097/01.sla.0000086658.60555.ea. PubMed 14501509 ↗
  • Mimura T, Rizzello F, Helwig U, Poggioli G, Schreiber S, Talbot IC, Nicholls RJ, Gionchetti P, Campieri M, Kamm MA. Once daily high dose probiotic therapy (VSL#3) for maintaining remission in recurrent or refractory pouchitis. Gut. 2004 Jan;53(1):108-14. doi: 10.1136/gut.53.1.108. PubMed 14684584 ↗
  • Mowat C, Cole A, Windsor A, Ahmad T, Arnott I, Driscoll R, Mitton S, Orchard T, Rutter M, Younge L, Lees C, Ho GT, Satsangi J, Bloom S; IBD Section of the British Society of Gastroenterology. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2011 May;60(5):571-607. doi: 10.1136/gut.2010.224154. PubMed 21464096 ↗
  • Ng SC, Plamondon S, Kamm MA, Hart AL, Al-Hassi HO, Guenther T, Stagg AJ, Knight SC. Immunosuppressive effects via human intestinal dendritic cells of probiotic bacteria and steroids in the treatment of acute ulcerative colitis. Inflamm Bowel Dis. 2010 Aug;16(8):1286-98. doi: 10.1002/ibd.21222. PubMed 20155842 ↗
  • Nguyen N, Zhang B, Holubar SD, Pardi DS, Singh S. Treatment and prevention of pouchitis after ileal pouch-anal anastomosis for chronic ulcerative colitis. Cochrane Database Syst Rev. 2019 Nov 30;11(11):CD001176. doi: 10.1002/14651858.CD001176.pub5. PubMed 31785173 ↗
  • Pardi DS, D'Haens G, Shen B, Campbell S, Gionchetti P. Clinical guidelines for the management of pouchitis. Inflamm Bowel Dis. 2009 Sep;15(9):1424-31. doi: 10.1002/ibd.21039. PubMed 19685489 ↗
  • Pathirana WGW, Chubb SP, Gillett MJ, Vasikaran SD. Faecal Calprotectin. Clin Biochem Rev. 2018 Aug;39(3):77-90. PubMed 30828114 ↗
  • Pronio A, Montesani C, Butteroni C, Vecchione S, Mumolo G, Vestri A, Vitolo D, Boirivant M. Probiotic administration in patients with ileal pouch-anal anastomosis for ulcerative colitis is associated with expansion of mucosal regulatory cells. Inflamm Bowel Dis. 2008 May;14(5):662-8. doi: 10.1002/ibd.20369. PubMed 18240282 ↗
  • Sagar PM, Taylor BA, Godwin P, Holdsworth PJ, Johnston D, Lewis W, Miller A, Quirke P, Williamson M. Acute pouchitis and deficiencies of fuel. Dis Colon Rectum. 1995 May;38(5):488-93. doi: 10.1007/BF02148848. PubMed 7736879 ↗
  • Sedano R, Ma C, Pai RK, D' Haens G, Guizzetti L, Shackelton LM, Remillard J, Gionchetti P, Gordon IO, Holubar S, Kayal M, Lauwers GY, Pai RK, Pardi DS, Samaan MA, Schaeffer DF, Shen B, Silverberg MS, Feagan BG, Sandborn WJ, Jairath V. An expert consensus to standardise clinical, endoscopic and histologic items and inclusion and outcome criteria for evaluation of pouchitis disease activity in clinical trials. Aliment Pharmacol Ther. 2021 May;53(10):1108-1117. doi: 10.1111/apt.16328. Epub 2021 Mar 18. PubMed 33735522 ↗
  • Shen B. Acute and chronic pouchitis--pathogenesis, diagnosis and treatment. Nat Rev Gastroenterol Hepatol. 2012 Apr 17;9(6):323-33. doi: 10.1038/nrgastro.2012.58. PubMed 22508158 ↗
  • Shen B, Achkar JP, Connor JT, Ormsby AH, Remzi FH, Bevins CL, Brzezinski A, Bambrick ML, Fazio VW, Lashner BA. Modified pouchitis disease activity index: a simplified approach to the diagnosis of pouchitis. Dis Colon Rectum. 2003 Jun;46(6):748-53. doi: 10.1007/s10350-004-6652-8. PubMed 12794576 ↗
  • Shen B, Achkar JP, Lashner BA, Ormsby AH, Remzi FH, Brzezinski A, Bevins CL, Bambrick ML, Seidner DL, Fazio VW. A randomized clinical trial of ciprofloxacin and metronidazole to treat acute pouchitis. Inflamm Bowel Dis. 2001 Nov;7(4):301-5. doi: 10.1097/00054725-200111000-00004. PubMed 11720319 ↗
  • Singh S, Feuerstein JD, Binion DG, Tremaine WJ. AGA Technical Review on the Management of Mild-to-Moderate Ulcerative Colitis. Gastroenterology. 2019 Feb;156(3):769-808.e29. doi: 10.1053/j.gastro.2018.12.008. Epub 2018 Dec 18. PubMed 30576642 ↗
  • Sood A, Midha V, Makharia GK, Ahuja V, Singal D, Goswami P, Tandon RK. The probiotic preparation, VSL#3 induces remission in patients with mild-to-moderately active ulcerative colitis. Clin Gastroenterol Hepatol. 2009 Nov;7(11):1202-9, 1209.e1. doi: 10.1016/j.cgh.2009.07.016. Epub 2009 Jul 22. PubMed 19631292 ↗
  • Spiegel BM, Reid MW, Bolus R, Whitman CB, Talley J, Dea S, Shahedi K, Karsan H, Teal C, Melmed GY, Cohen E, Fuller G, Yen L, Hodgkins P, Erder MH. Development and validation of a disease-targeted quality of life instrument for chronic diverticular disease: the DV-QOL. Qual Life Res. 2015 Jan;24(1):163-79. doi: 10.1007/s11136-014-0753-1. Epub 2014 Jul 25. PubMed 25059533 ↗
  • Tursi A, Brandimarte G, Papa A, Giglio A, Elisei W, Giorgetti GM, Forti G, Morini S, Hassan C, Pistoia MA, Modeo ME, Rodino' S, D'Amico T, Sebkova L, Sacca' N, Di Giulio E, Luzza F, Imeneo M, Larussa T, Di Rosa S, Annese V, Danese S, Gasbarrini A. Treatment of relapsing mild-to-moderate ulcerative colitis with the probiotic VSL#3 as adjunctive to a standard pharmaceutical treatment: a double-blind, randomized, placebo-controlled study. Am J Gastroenterol. 2010 Oct;105(10):2218-27. doi: 10.1038/ajg.2010.218. Epub 2010 Jun 1. PubMed 20517305 ↗
  • Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. PubMed 1593914 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2023 (actual). Primary completion is estimated for May 2027, 42 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 30, 2023
First posted
Jul 10, 2023
StartActual
Nov 6, 2023
Primary completionEst.
May 31, 2027
CompletionEst.
Jul 31, 2027
Last update
May 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05938465
Lead sponsor
Exegi Pharma, LLC
Collaborators
The Emmes Company, LLC
Responsible party
Sponsor
First posted
Jul 10, 2023
Start date
Nov 6, 2023
Primary completion
May 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
May 28, 2026

Study contacts

Emmes Project Management
Contact
PROF_Study@emmes.com
301-251-1161
Julia Collins, MS
study director · Exegi Pharma, LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pouchitis →

Start the discussion