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.

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19-120
SponsorPharmaPlanter Technologies Inc

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

63 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Locations

This trial has no locations

Sponsors and collaborators