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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.

NCT06948461 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-04-29

No results posted yet for this study

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

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 & Collaborators

  • PharmaPlanter Technologies Inc

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-09-30
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06948461 on ClinicalTrials.gov