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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT06028035
Eligibility Criteria:
Inclusion criteria
1. Prior diagnosis of bile acid diarrhea as documented by either
1. total bile acid in 48 hour stool excretion of 2337 micromoles per 48 hours, or
2. greater than 1000 micromoles per 48 hours with greater than 4% primary bile acids in stool, or
3. greater than 10% primary bile acid (CA and CDCA) in stool 48 hour collection, or
4. serum 7 alpha C4 greater than 52 ng/mL
2. BMI \<40 kg/m2.
3. Prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study.
4. Participants receiving bile acid sequestrant will not be permitted to continue therapy. and need to stop one week before baseline test.
5. No use of oral antibiotics and NSAIDs for 2 weeks prior to study treatment
Exclusion criteria
1. Diabetes mellitus (type 1)
2. Diabetes mellitus type 2 if taking metformin or GLP-1 agonist treatment (exenatide, liraglutide, semaglutide)
3. Uncontrolled hypertension (with BP measured \>140/90mmHg in the CRTU)
4. BMI ≥40 kg/m2
5. Chronic NSAID use (\>1 day/week)
6. Use of oral antibiotics and NSAIDs for 2 weeks prior to and during the entire 21 day study period
7. Use of bile acid sequestrant for 1 week prior to and during the entire 21 day study period
8. Diagnosis of gastrointestinal diseases that are associated with inflammation such as inflammatory bowel diseases and celiac disease or gastrointestinal infection in the prior 4 weeks;
9. Prior intestinal or colonic resection; note prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study
10. Participation in highly vigorous exercise such as running \>5 miles per day in week prior to the permeability test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06028035
Study Brief:
Protocol Section:
NCT06028035