Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2025-12-24 @ 12:55 PM
NCT ID:
NCT06948461
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:
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
120 Years
Study:
NCT06948461
Study Brief:
Protocol Section:
NCT06948461