Status:
NOT_YET_RECRUITING
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.
Lead Sponsor:
PharmaPlanter Technologies Inc
Conditions:
Irritable Bowel Syndrome, Diarrhea-Predominant (IBS-D)
Recurrent Clostridioides Difficile Infection (rCDI)
Eligibility:
All Genders
19-120 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 19 years of age and older
- Able to provide informed consent
- Must have at least one of the 3 following conditions:
- 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:
- Recurrent abdominal pain/discomfort\*\* at least 3 days/month in last 3 months associated with ≥2 of the following:
- Symptom improvement with defecation;
- Onset associated with change in stool frequency;
- Onset associated with change in stool formation (with this last criterion fulfilled for last 3 months with symptom onset \> 6 months prior to diagnosis
- 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.
- 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
- 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 \[Consumption of yogurt is permitted\]
- Severe allergy to any food and/or medications
- Major open abdominal surgery within the past 60 days
- Receipt of chemotherapy or radiation within 8 weeks of screening.
- Active small bowel obstruction.
- 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.
- Those who are breastfeeding or plan to breast feed during the trial
- Not expected to survive beyond 30 days.
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06948461
Start Date
September 1 2025
End Date
December 1 2026
Last Update
April 29 2025
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