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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