Status:
COMPLETED
A Study of Hemp Hull WFI for IBS Diarrhea
Lead Sponsor:
Mayo Clinic
Conditions:
Irritable Bowel Syndrome-bile Acid Diarrhea
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this study is the effect of a study bar, which contains 15 grams of insoluble dietary fiber total sourced from Hemp hulls, on intestinal permeability in irritable bowel syndrome (IBS)-b...
Detailed Description
Patients with irritable bowel syndrome-bile acid diarrhea (IBS-BAD) have no evidence of significant histologically-evident inflammation or ulceration. The condition is often unrecognized in comparison...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Prior diagnosis of bile acid diarrhea as documented by either
- total bile acid in 48 hour stool excretion of 2337 micromoles per 48 hours, or
- greater than 1000 micromoles per 48 hours with greater than 4% primary bile acids in stool, or
- greater than 10% primary bile acid (CA and CDCA) in stool 48 hour collection, or
- serum 7 alpha C4 greater than 52 ng/mL
- BMI \<40 kg/m2.
- Prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study.
- Participants receiving bile acid sequestrant will not be permitted to continue therapy. and need to stop one week before baseline test.
- No use of oral antibiotics and NSAIDs for 2 weeks prior to study treatment
- Exclusion criteria
- Diabetes mellitus (type 1)
- Diabetes mellitus type 2 if taking metformin or GLP-1 agonist treatment (exenatide, liraglutide, semaglutide)
- Uncontrolled hypertension (with BP measured \>140/90mmHg in the CRTU)
- BMI ≥40 kg/m2
- Chronic NSAID use (\>1 day/week)
- Use of oral antibiotics and NSAIDs for 2 weeks prior to and during the entire 21 day study period
- Use of bile acid sequestrant for 1 week prior to and during the entire 21 day study period
- 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;
- Prior intestinal or colonic resection; note prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study
- Participation in highly vigorous exercise such as running \>5 miles per day in week prior to the permeability test
Exclusion
Key Trial Info
Start Date :
October 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06028035
Start Date
October 6 2023
End Date
May 1 2024
Last Update
June 5 2024
Active Locations (1)
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1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905