CompletedNo phase
A Study of Hemp Hull WFI for IBS Diarrhea
Key facts
- Who runs it
- Mayo Clinic
- Where
- Rochester, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 10 people enrolled
- Started
- 6 Oct 2023
- Ended
- 1 May 2024
- Type of study
- Interventional
- Treatments tested
- BB01
- Record updated
- 5 June 2024
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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)
Where in United States
- Mayo Clinic MinnesotaRochester, United StatesNo longer taking part
About the trial
What the trial wants to find out
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)-bile acid diarrhea individuals.
The group in the trial
- BB01 Supplement BarsTreatment being tested
Subjects will consume two BB01 supplement bars daily for 21 days.
Treatment: BB01
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Pilot Study of Hemp Hull WFI (BB01) to Reduce Intestinal Permeability in IBS-Diarrhea With Evidence of Bile Acid Diarrhea
- Record updated
- 5 June 2024