CompletedNot Applicable

A Study of Hemp Hull WFI for IBS Diarrhea

United States10 participantsStarted 2023-10-06

Plain-language 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)-bile acid diarrhea individuals.

Who can participate

Age range18 Years – 70 Years

SexALL

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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.

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;

What they're measuring

Change in urinary excretion of 13^C-mannitol

Timeframe: Baseline, 3 weeks

Change in urinary excretion of lactulose

Timeframe: Baseline, 3 weeks

Trial details

NCT IDNCT06028035

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-31

View on ClinicalTrials.gov More Irritable Bowel Syndrome-bile Acid Diarrhea trials