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NCT Number: NCT06948461

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.

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 19 years of age and older
  • Able to provide informed consent
  • Must have at least one of the 3 following conditions:
  • 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:
  • Recurrent abdominal pain/discomfort** at least 3 days/month in last 3 months associated with ≥2 of the following:
  • Symptom improvement with defecation;
  • Onset associated with change in stool frequency;
  • Onset associated with change in stool formation (with this last criterion fulfilled for last 3 months with symptom onset > 6 months prior to diagnosis
  • 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.
  • 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

  • Planned or actively taking other investigational product
  • Unable to tolerate FMT or take oral medications.
  • Requiring systemic antibiotic therapy at the time of FMT
  • Actively taking probiotics [Consumption of yogurt is permitted]
  • Severe allergy to any food and/or medications
  • Major open abdominal surgery within the past 60 days
  • Receipt of chemotherapy or radiation within 8 weeks of screening.
  • Active small bowel obstruction.
  • 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.
  • Those who are breastfeeding or plan to breast feed during the trial
  • Not expected to survive beyond 30 days.
  • 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

-

Treatment and study plan

ORAL-LYO-FMT

Biological

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.

Placebo

Other

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.

Primary outcomes

  1. Prevention of Recurrent CDI

    Time frame: 8 weeks after completion of IP

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

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

    Time frame: 8 weeks after completion of IP

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

Secondary outcomes

  1. CDI Recurrence Prevention at 24 Weeks

    Time frame: 24 weeks post-treatment

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

  2. Longitudinal IBS-SSS Improvement

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

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

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

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

    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.

  4. Hospital Anxiety and Depression Scale (HADS)

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

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

  5. Chronic Condition Changes

    Time frame: 24 weeks after completion of IP

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

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

    Time frame: Up to 8 weeks after completion of IP

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

Sponsors and collaborators

Lead sponsor

PharmaPlanter Technologies Inc

Network

Registry information

Official study title

An Adaptive Basket Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Therapy in Management of Irritable Bowel Syndrome-diarrhea Predominant or Prevention of Recurrent Clostridioides Difficile Infection

Acronym: ORAL-LYO-FMT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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