About this trial
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.
Eligibility criteria
Qualifiers
19 years of age and older
Able to provide informed consent
Symptom improvement with defecation;
Onset associated with change in stool frequency;
Disqualifiers
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]
Trial design
Treatments tested in this trial
- ORAL-LYO-FMT
- Placebo
Treatment groups
9
Treatment groupsSee each treatment group below.