A Study of Hemp Hull WFI for IBS Diarrhea

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome-bile Acid Diarrhea
• Interventions: Dietary Supplement: BB01

• Registration Number: NCT06028035
• Lead Sponsor: Mayo Clinic

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)-bile acid diarrhea individuals.

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 with natural variations in bowel function in the general population. Hemp seeds are a complete source of protein, providing all nine essential amino acids, as well as polyunsaturated fats, especially omega-3 fatty acid, fiber, minerals and vitamins. Hemp hulls, the outer shell of the seeds, are typically rich in dietary fiber and phenolics and showed to have a beneficial effect on gut barrier function in vitro.

To demonstrate reduced intestinal permeability after 3 weeks of BB01 (20g of BB01, which reflects 15g of insoluble dietary fiber) consumption in a group of 10 patients with IBS-diarrhea with evidence of bile acid diarrhea, a group that has been previously documented to have increased GI permeability.

Study Timeline

• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-08-31
• Study First Posted: 2023-09-07
• Status Verified: 2023-10
• Study Start: 2023-10-06
• Primary Completion: 2024-03-31
• Study Completion: 2024-05-01
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BB01 Supplement Bars	BB01	Subjects will consume two BB01 supplement bars daily for 21 days.

Primary Outcome Measures

Name	Time	Method
Change in urinary excretion of 13^C-mannitol	Baseline, 3 weeks	Percent urinary excretion of 13\^C-mannitol
Change in urinary excretion of lactulose	Baseline, 3 weeks	Percent urinary excretion of lactulose

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States