Clinical Trial

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.

Study acronym: ORAL-LYO-FMT
Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT06948461
Lead Sponsor PharmaPlanter Technologies Inc
Conditions Irritable Bowel Syndrome, Diarrhea-Predominant (IBS-D), Recurrent Clostridioides Difficile Infection (rCDI), Fecal Microbiota Therapy (FMT), Irritable Bowel Syndrome (IBS), Clostridioides Difficile Infection
Enrollment 63 participants
Start Date 2025-09-01
Primary Completion 2026-09 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-04-29