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Not yet recruitingNCT06948461ORAL-LYO-FMTUpdated Apr 29, 2025

A Flexible Clinical Trial to Test if Freeze-dried Fecal Microbiota Therapy Helps Treat Diarrhea-predominant Irritable Bowel Syndrome or Prevent Recurring C. Difficile Infections.

A Phase 2 interventional study of ORAL-LYO-FMT and Placebo in Irritable Bowel Syndrome, Diarrhea-Predominant (IBS-D), Recurrent Clostridioides Difficile Infection (rCDI) and Fecal Microbiota Therapy (FMT), sponsored by PharmaPlanter Technologies Inc. Not yet recruiting. Open to participants aged 19 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-04-29.

Sponsored by PharmaPlanter Technologies Inc · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
19 Years to 120 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn if oral lyophilized fecal microbiota therapy (ORAL-LYO-FMT) helps treat diarrhea-predominant irritable bowel syndrome (IBS-D) and prevent the recurrence of Clostridioides difficile infection (rCDI). The main questions it aims to answer are:

  • Does ORAL-LYO-FMT reduce IBS symptoms?
  • Does it prevent rCDI after treatment?
  • What side effects or safety concerns might occur? Researchers will compare ORAL-LYO-FMT to a placebo (a look-alike capsule with no active treatment) to see how well it works.

Participants will:

  • Be randomly assigned to take ORAL-LYO-FMT or placebo for up to 7 weeks
  • Take capsules three times per week (Monday, Wednesday, Friday)
  • Complete health questionnaires and have follow-up visits by phone or in person for up to 6 months The trial also looks at changes in quality of life, mood, and new or ongoing medical conditions over time.
02

Conditions studied

  • Irritable Bowel Syndrome, Diarrhea-Predominant (IBS-D)
  • Recurrent Clostridioides Difficile Infection (rCDI)
  • Fecal Microbiota Therapy (FMT)
  • Irritable Bowel Syndrome (IBS)
  • Clostridioides Difficile Infection

Keywords

  • IBS
  • Irritable bowel syndrome
  • rCDI
  • Fecal Microbiota Therapy
  • FMT
  • Gut Health
  • CDI
  • Clostridioides difficile infection, Recurrent
03

In context

Irritable Bowel Syndrome

1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.

This study's planned enrollment of 63 is close to the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

This is the only study on the registry with PharmaPlanter Technologies Inc as lead sponsor.

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

04

Who can participate

Ages eligible
19 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 19 years of age and older
  • Able to provide

  • Must have at least one of the 3 following conditions:

    1. Irritable bowel syndrome with diarrhea- predominant (IBS-D) as reported by patients of type 6 or 7 in Bristol stool chart and Rome IV diagnostic criteria:

      1. Recurrent abdominal pain/discomfort** at least 3 days/month in last 3 months associated with ≥2 of the following:
      2. Symptom improvement with defecation;
      3. Onset associated with change in stool frequency;
      4. Onset associated with change in stool formation (with this last criterion fulfilled for last 3 months with symptom onset > 6 months prior to diagnosis
    2. Primary or 1 episode recurrent Clostridioides difficile infection which is actively treated with CDI antibiotic (oral vancomycin, oral metronidazole or fidaxomicin) and clinically responding to treatment based on physician assessment at the time of recruitment.
    3. 2 or more episodes of recurrent Clostridioides difficile infection, which is actively treated with CDI antibiotic (oral vancomycin, oral metronidazole or fidaxomicin) and clinically responding to treatment based on physician assessment at the time of recruitment.

Exclusion Criteria:

  1. Planned or actively taking other product
  2. Unable to tolerate FMT or take oral medications.
  3. Requiring systemic antibiotic therapy at the time of FMT
  4. Actively taking probiotics [Consumption of yogurt is permitted]
  5. Severe allergy to any food and/or medications
  6. Major open abdominal surgery within the past 60 days
  7. Receipt of chemotherapy or radiation within 8 weeks of screening.
  8. Active small bowel obstruction.
  9. Those who are pregnant or plan to be pregnant within 3 months of the study. This will be determined on history alone at time of study entry and subsequent follow up.
  10. Those who are breastfeeding or plan to breast feed during the trial
  11. Not expected to survive beyond 30 days.
  12. Any current or previous medical or psychosocial condition or behaviours which in the opinion of the investigator may pose risk to the recipients or the study team

Exclusion Criteria:

-

Terms in these criteria, in plain language(2)

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.

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.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
63 participants (estimated)

Study arms

  • Experimental
    IBS-D - ORAL-LYO-FMT 7 Weeks

    Participants with diarrhea-predominant irritable bowel syndrome (IBS-D) receive 7 oral capsules of ORAL-LYO-FMT three times per week (Monday, Wednesday, Friday) for 7 weeks.

    Biological: ORAL-LYO-FMT

  • Placebo comparator
    IBS-D - Placebo 7 Weeks

    Participants with IBS-D receive 7 oral placebo capsules (double-coated and visually identical to active capsules) three times per week for 7 weeks.

    Other: Placebo

  • Experimental
    IBS-D - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks

    Participants with IBS-D receive 7 oral capsules of ORAL-LYO-FMT three times per week for 4 weeks, followed by 7 oral placebo capsules three times per week for 3 weeks.

    Biological: ORAL-LYO-FMT

  • Experimental
    Primary/1st rCDI - ORAL-LYO-FMT 7 Weeks

    Participants with a primary or first episode of recurrent Clostridioides difficile infection (rCDI) receive 7 oral capsules of ORAL-LYO-FMT three times per week for 7 weeks.

    Biological: ORAL-LYO-FMT

  • Placebo comparator
    Primary/1st rCDI - Placebo 7 Weeks

    Participants with primary or first episode rCDI receive 7 oral placebo capsules three times per week for 7 weeks.

    Other: Placebo

  • Experimental
    Primary/1st rCDI - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks

    Participants with primary or first episode rCDI receive 7 oral capsules of ORAL-LYO-FMT three times per week for 4 weeks, followed by placebo capsules three times per week for 3 weeks.

    Biological: ORAL-LYO-FMT

  • Experimental
    ≥2 rCDI - ORAL-LYO-FMT 7 Weeks

    Participants with two or more episodes of rCDI receive 7 oral capsules of ORAL-LYO-FMT three times per week for 7 weeks.

    Biological: ORAL-LYO-FMT

  • Placebo comparator
    ≥2 rCDI - Placebo 7 Weeks

    Participants with two or more episodes of rCDI receive 7 oral placebo capsules three times per week for 7 weeks.

    Other: Placebo

  • Experimental
    ≥2 rCDI - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks

    Participants with two or more episodes of rCDI receive 7 oral capsules of ORAL-LYO-FMT three times per week for 4 weeks, followed by 3 weeks of placebo capsules.

    Biological: ORAL-LYO-FMT

Interventions

  • BiologicalORAL-LYO-FMT

    An oral capsule formulation of lyophilized fecal microbiota. Participants receive 7 capsules, three times per week (Monday, Wednesday, Friday), for either 4 or 7 weeks depending on treatment allocation. The product aims to restore healthy gut microbiota for treatment of IBS-D or prevention of rCDI.

  • OtherPlacebo

    Double-coated oral capsules visually identical to ORAL-LYO-FMT but containing no active material. Participants receive 7 capsules, three times per week, for either 3 or 7 weeks depending on treatment allocation.

06

What researchers measure

Primary outcomes

  1. Prevention of Recurrent CDI

    Proportion of participants with Clostridioides difficile infection (CDI) who do not experience recurrence within 8 weeks following completion of the investigational product (IP).

    Time frame: 8 weeks after completion of IP

  2. Improvement in IBS Symptom Severity (IBS-SSS)

    Proportion of IBS-D participants with a reduction in IBS Symptom Severity Score (IBS-SSS) of more than 150 points compared to baseline.

    Time frame: 8 weeks after completion of IP

Secondary outcomes

  1. CDI Recurrence Prevention at 24 Weeks

    Proportion of participants with CDI who remain recurrence-free 24 weeks after IP completion.

    Time frame: 24 weeks post-treatment

  2. Longitudinal IBS-SSS Improvement

    Proportion of IBS-D participants with sustained improvement in IBS-SSS at 1, 3, and 6 months after IP completion.

    Time frame: 1, 3, and 6 months post-treatment

  3. Quality of Life (VR-12 Score Change)

    Change in Veterans RAND 12 Item Health Survey (VR-12) scores at baseline, 4 weeks from IP initiation, and 12 and 24 weeks post-IP.

    Time frame: Baseline, Week 4, Week 12, and Week 24

  4. Hospital Anxiety and Depression Scale (HADS)

    Change in HADS scores from baseline to 4, 12, and 24 weeks post-IP.

    Time frame: Baseline, Week 4, Week 12, and Week 24

  5. Chronic Condition Changes

    Proportion of participants with onset of new or improvement in existing chronic conditions, as reported in long-term follow-up questionnaire.

    Time frame: 24 weeks after completion of IP

  6. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number and severity of AEs or SAEs possibly or definitely related to IP, assessed via Naranjo Causality Assessment Scale.

    Time frame: Up to 8 weeks after completion of IP

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2025; primary completion for Sep 2026, 12 months later.

Of 42 phase 2 interventional studies under Irritable Bowel Syndrome, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 39. This study's planned 12 months is below that.

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

Registered
Apr 21, 2025
First posted
Apr 29, 2025
StartEst.
Sep 1, 2025
Primary completionEst.
Sep 2026
CompletionEst.
Dec 2026
Last update
Apr 29, 2025
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 Apr 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06948461
Lead sponsor
PharmaPlanter Technologies Inc
Responsible party
Sponsor
First posted
Apr 29, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 29, 2025

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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