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.

Launched by PHARMAPLANTER TECHNOLOGIES INC · Apr 21, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called oral lyophilized fecal microbiota therapy (ORAL-LYO-FMT) to see if it can help people with diarrhea-predominant irritable bowel syndrome (IBS-D) and prevent recurrent Clostridioides difficile infections (rCDI). The researchers want to find out if this treatment reduces IBS symptoms, helps prevent rCDI after antibiotic treatment, and what side effects might occur. Participants will take either the ORAL-LYO-FMT capsules or a placebo (a dummy treatment) three times a week for up to seven weeks and will be followed for up to six months to monitor their health and quality of life.

To be eligible for this trial, participants must be 19 years or older and have one of the following conditions: IBS-D, a primary or recurrent C. difficile infection that is being treated, or multiple episodes of C. difficile infection. Participants cannot be pregnant, breastfeeding, or have certain medical conditions that could interfere with the study. Throughout the trial, participants will complete health questionnaires and may have follow-up visits by phone or in person.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 19 years of age and older
• • Able to provide informed consent
• * Must have at least one of the 3 following conditions:
• 1. Irritable bowel syndrome with diarrhea- predominant (IBS-D) as reported by patients of type 6 or 7 in Bristol stool chart and Rome IV diagnostic criteria:
• 1. Recurrent abdominal pain/discomfort\*\* at least 3 days/month in last 3 months associated with ≥2 of the following:
• • 2. Symptom improvement with defecation;
• • 3. Onset associated with change in stool frequency;
• • 4. Onset associated with change in stool formation (with this last criterion fulfilled for last 3 months with symptom onset \> 6 months prior to diagnosis
• • 2. Primary or 1 episode recurrent Clostridioides difficile infection which is actively treated with CDI antibiotic (oral vancomycin, oral metronidazole or fidaxomicin) and clinically responding to treatment based on physician assessment at the time of recruitment.
• • 3. 2 or more episodes of recurrent Clostridioides difficile infection, which is actively treated with CDI antibiotic (oral vancomycin, oral metronidazole or fidaxomicin) and clinically responding to treatment based on physician assessment at the time of recruitment.
• Exclusion Criteria:
• • 1. Planned or actively taking other investigational product
• • 2. Unable to tolerate FMT or take oral medications.
• • 3. Requiring systemic antibiotic therapy at the time of FMT
• • 4. Actively taking probiotics \[Consumption of yogurt is permitted\]
• • 5. Severe allergy to any food and/or medications
• • 6. Major open abdominal surgery within the past 60 days
• • 7. Receipt of chemotherapy or radiation within 8 weeks of screening.
• • 8. Active small bowel obstruction.
• • 9. Those who are pregnant or plan to be pregnant within 3 months of the study. This will be determined on history alone at time of study entry and subsequent follow up.
• • 10. Those who are breastfeeding or plan to breast feed during the trial
• • 11. Not expected to survive beyond 30 days.
• • 12. Any current or previous medical or psychosocial condition or behaviours which in the opinion of the investigator may pose risk to the recipients or the study team
• Exclusion Criteria:
• • -