A Phase 1/2 interventional study of Active FMT, then open label FMT and Placebo FMT, then open label FMT in Pouchitis, sponsored by University of North Carolina, Chapel Hill. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-05-14.
Sponsored by University of North Carolina, Chapel Hill · Phase 1/2, Interventional, and Treatment
Antibiotic dependent pouchitis (ADP) is predestined to benefit from FMT, since bacterial dysbiosis, which can only be controlled with antibiotics, appears to be the major driver of the clinical symptoms. This is a proof of concept randomized placebo controlled trial, in which 50% of the patients will receive FMT and 50% will receive a placebo FMT. Additionally the trial offers an open label extension period.
FMT for ADP is a promising approach, given the documented role of bacteria in the pathogenesis. In contrast to patients with C. difficile colitis, in whom a single FMT is highly effective, in patients with Inflammatory Bowel Disease (IBD) an intensified therapy with daily or repeated FMT may be more beneficial. Whereas repeated endoscopic application are not feasible and repeated enema applications are not favored by patients a combination of endoscopic FMT and consecutive maintenance therapy with oral FMT using the FMT capsule G3 produced by OpenBiome to help establish the donor microbiome in the host seems to be the most promising approach. The objective of this trial is to evaluate the safety of FMT in patients with ADP and to estimate the effect size to be achieved from FMT therapy in patients with ADP for subsequent evaluation in a large definitive trial. A secondary objective is to study the microbial engraftment of donor FMT in the recipients.
This proof of concept randomized placebo controlled trial with an open label extension period will evaluate the safety and efficacy of an initial endoscopic FMT followed by 14 days of oral FMT. The study has two distinct outcomes, a clinical and translational aim, to investigate the effect of FMT in patients with ADP.
Aim1: Evaluation of safety, tolerability and clinical effectiveness (measured as clinical response or remission and discontinuation of antibiotic therapy) of FMT in patients with ADP.
Aim 2: Evaluation of the impact of FMT on the fecal bacterial microbiome in patients with ADP, which will provide functional data about possible mechanisms of this therapy.
50 studies on the registry are indexed under Pouchitis; 12 are open to participants now.
This study's enrollment of 6 is below the median of 20 across 42 interventional studies indexed under Pouchitis.
Browse Pouchitis studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
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.
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.
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Biological: Active FMT, then open label FMT
Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Biological: Placebo FMT, then open label FMT
Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Also known as: Active FMT
Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Also known as: Placebo FMT
Number of Patients With FMT Related Adverse Event
Number of patients with FMT related adverse event (classified according to MedDRA; lowest level term) and categorized according to CTCAE Version 4.0. The safety was assessed in the randomized placebo controlled segment of the study over 24 weeks after initial endoscopic FMT weeks and if the patient should enter the open label extension part of the study also for 24 weeks after initial open label FMT. 6 patients participated in the randomized arm and 5 patients in the open label extension arm.
Time frame: 24 weeks
Number of Patients in Clinical Remission Week 4 After Endoscopic and Oral FMT
Clinical remission as defined by a composite assessment, of which all criteria need to be met: Clinical modified pouch diseases activity index (mPDAI) score ≤4 points and no need for antibiotic therapy at week 4.
Time frame: 4 weeks
Number of Patients in Clinical Remission Week 16
Clinical remission as defined by a composite assessment, of which all criteria need to be met: Clinical mPDAI score ≤4 points and no need for antibiotic therapy at week 16.
Time frame: 16 weeks
Number of Patients With Endoscopic Improvement Week 4 After Endoscopic and Oral FMT
Endoscopic improvement of active pouchitis (decrease from baseline in modified pouch disease activity index endoscopic subscore \> 2 points) at week 4.
Time frame: 4 weeks
Number of Patients With Clinical Response at Week 4 in Patients Entering the Trial With Active Pouchitis Symptoms
This outcome measure is for patients with active pouchitis symptoms entering the trial. Since all patients entered with inactive pouchitis no patient could be evaluated for this outcome. Response as defined by a composite assessment of which both criteria has to be met: Decrease from baseline mPDAI clinical subscore \> 2 points and no need for antibiotic therapy at week 4.
Time frame: 4 weeks
Number of Patients With Clinical Response Week 8 and Active Pouchitis at Baseline
Response as defined by a composite assessment of which both criteria has to be met: Decrease from baseline mPDAI clinical subscore \> 2 points and no need for antibiotic therapy at week 8 of the randomized phase.
Time frame: 8 weeks
Number of Patients With Clinical Response i at Week 16 and Active Pouchitis at Baseline
This outcome measure is for patients with active pouchitis symptoms entering the trial. Response as defined by a composite assessment of which both criteria has to be met: Decrease from baseline mPDAI clinical subscore \> 2 points and no need for antibiotic therapy at week 16.
Time frame: 16 weeks
| Milestone | Active FMT, Then Open Label FMT | Placebo FMT, Then Open Label FMT | Open Label FMT Period |
|---|---|---|---|
| Started | 4 | 2 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 4 | 2 | 0 |
| Withdrew: Lack of efficacy | 4 | 2 | 0 |
| Milestone | Active FMT, Then Open Label FMT | Placebo FMT, Then Open Label FMT | Open Label FMT Period |
|---|---|---|---|
| Started | 0 | 0 | 5 |
| Completed | 0 | 0 | 1 |
| Not completed | 0 | 0 | 4 |
| Withdrew: Lack of efficacy | 0 | 0 | 4 |
Number of patients with FMT related adverse event (classified according to MedDRA; lowest level term) and categorized according to CTCAE Version 4.0. The safety was assessed in the randomized placebo controlled segment of the study over 24 weeks after initial endoscopic FMT weeks and if the patient should enter the open label extension part of the study also for 24 weeks after initial open label FMT. 6 patients participated in the randomized arm and 5 patients in the open label extension arm.
| Participants | Randomized Phase: Active FMT | Randomized Phase: Placebo | Open Label FMT |
|---|---|---|---|
| Number of Patients With FMT Related Adverse Event | 0 | 0 | 0 |
Clinical remission as defined by a composite assessment, of which all criteria need to be met: Clinical modified pouch diseases activity index (mPDAI) score ≤4 points and no need for antibiotic therapy at week 4.
| Participants | Randomized Phase: Active FMT | Randomized Phase: Placebo | Open Label FMT |
|---|---|---|---|
| Number of Patients in Clinical Remission Week 4 After Endoscopic and Oral FMT | 0 | 0 | 1 |
Clinical remission as defined by a composite assessment, of which all criteria need to be met: Clinical mPDAI score ≤4 points and no need for antibiotic therapy at week 16.
| Participants | Randomized Phase: Active FMT | Randomized Phase: Placebo | Open Label FMT |
|---|---|---|---|
| Number of Patients in Clinical Remission Week 16 | 0 | 0 | 1 |
Endoscopic improvement of active pouchitis (decrease from baseline in modified pouch disease activity index endoscopic subscore \> 2 points) at week 4.
| Participants | Randomized Phase: Active FMT | Randomized Phase: Placebo | Open Label FMT |
|---|---|---|---|
| Number of Patients With Endoscopic Improvement Week 4 After Endoscopic and Oral FMT | 0 | 0 | 0 |
This outcome measure is for patients with active pouchitis symptoms entering the trial. Since all patients entered with inactive pouchitis no patient could be evaluated for this outcome. Response as defined by a composite assessment of which both criteria has to be met: Decrease from baseline mPDAI clinical subscore \> 2 points and no need for antibiotic therapy at week 4.
No measurements were reported for this outcome.
Response as defined by a composite assessment of which both criteria has to be met: Decrease from baseline mPDAI clinical subscore \> 2 points and no need for antibiotic therapy at week 8 of the randomized phase.
| Participants | Randomized Phase: Active FMT | Randomized Phase: Placebo | Open Label FMT |
|---|---|---|---|
| Number of Patients With Clinical Response Week 8 and Active Pouchitis at Baseline | 0 | 0 | 0 |
This outcome measure is for patients with active pouchitis symptoms entering the trial. Response as defined by a composite assessment of which both criteria has to be met: Decrease from baseline mPDAI clinical subscore \> 2 points and no need for antibiotic therapy at week 16.
No measurements were reported for this outcome.
Collected over Adverse event were collected for 24 weeks after endoscopic FMT in the randomized phase. If patient the patient participated in the open label extension study period adverse events were collected for 24 weeks after endoscopic FMT in the open label extension phase.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Randomized Phase: Active FMT | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Randomized Phase: Placebo | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Open Label FMT | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Event | Randomized Phase: Active FMT | Randomized Phase: Placebo | Open Label FMT |
|---|---|---|---|
| BloatingGastrointestinal disorders | 3/4 | 2/2 | 3/5 |
| UrgencyGastrointestinal disorders | 3/4 | 0/2 | 1/5 |
| DiarrheaGastrointestinal disorders | 3/4 | 0/2 | 2/5 |
| NauseaGastrointestinal disorders | 0/4 | 1/2 | 0/5 |
| FatigueGeneral disorders | 0/4 | 1/2 | 1/5 |
| Age, Categorical(Participants) | Active FMT, Then Open Label FMT | Placebo FMT, Then Open Label FMT | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 2 | 6 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Active FMT, Then Open Label FMT | Placebo FMT, Then Open Label FMT | Total |
|---|---|---|---|
| Female | 0 | 2 | 2 |
| Male | 4 | 0 | 4 |
| Race (NIH/OMB)(Participants) | Active FMT, Then Open Label FMT | Placebo FMT, Then Open Label FMT | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 2 | 6 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Active FMT, Then Open Label FMT | Placebo FMT, Then Open Label FMT | Total |
|---|---|---|---|
| United States | 4 | 2 | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — The final results of the trial will be posted on clinical trials.gov. No individual patient data will be posted.
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