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.

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: PharmaPlanter Technologies Inc · Network
• Sex: All
• Age: 19 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	ORAL-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.
OTHER	Placebo	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2025-04-29
• Last updated: 2025-04-29