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.

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

December 31, 2026

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
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.

Sponsors
All Listed Sponsors
lead

PharmaPlanter Technologies Inc

NETWORK