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A Study of Hemp Hull WFI for IBS Diarrhea

Primary Purpose

Irritable Bowel Syndrome-bile Acid Diarrhea

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BB01
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Irritable Bowel Syndrome-bile Acid Diarrhea

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic MinnesotaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BB01 Supplement Bars

Arm Description

Subjects will consume two BB01 supplement bars daily for 21 days.

Outcomes

Primary Outcome Measures

Change in urinary excretion of 13^C-mannitol
Percent urinary excretion of 13^C-mannitol
Change in urinary excretion of lactulose
Percent urinary excretion of lactulose

Secondary Outcome Measures

Full Information

First Posted
August 31, 2023
Last Updated
October 10, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT06028035
Brief Title
A Study of Hemp Hull WFI for IBS Diarrhea
Official Title
A Pilot Study of Hemp Hull WFI (BB01) to Reduce Intestinal Permeability in IBS-Diarrhea With Evidence of Bile Acid Diarrhea
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome-bile Acid Diarrhea

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BB01 Supplement Bars
Arm Type
Experimental
Arm Description
Subjects will consume two BB01 supplement bars daily for 21 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
BB01
Intervention Description
20 grams minimally processed form of Hemp hulls in the form of a bar/wafer.
Primary Outcome Measure Information:
Title
Change in urinary excretion of 13^C-mannitol
Description
Percent urinary excretion of 13^C-mannitol
Time Frame
Baseline, 3 weeks
Title
Change in urinary excretion of lactulose
Description
Percent urinary excretion of lactulose
Time Frame
Baseline, 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monique Ferber
Phone
507-538-6599
Email
ferber.monique@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Irene Busciglio
Phone
507-266-6615
Email
busciglio.irene@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Camilleri, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

A Study of Hemp Hull WFI for IBS Diarrhea

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