A Study of Hemp Hull WFI for IBS Diarrhea

• Sponsor: Mayo Clinic (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06028035
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 9.9
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome-bile Acid Diarrhea	Dietary Supplement: BB01	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Pilot Study of Hemp Hull WFI (BB01) to Reduce Intestinal Permeability in IBS-Diarrhea With Evidence of Bile Acid Diarrhea
• Anticipated Study Start Date: Sep 2, 2023
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BB01 Supplement Bars Subjects will consume two BB01 supplement bars daily for 21 days.	Dietary Supplement: BB01; 20 grams minimally processed form of Hemp hulls in the form of a bar/wafer.

Outcome Measures

Primary Outcome Measures

1. Change in urinary excretion of 13^C-mannitol [Baseline, 3 weeks]

   Percent urinary excretion of 13^C-mannitol

2. Change in urinary excretion of lactulose [Baseline, 3 weeks]

   Percent urinary excretion of lactulose

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

1. Prior diagnosis of bile acid diarrhea as documented by either

2. total bile acid in 48 hour stool excretion of 2337 micromoles per 48 hours, or

3. greater than 1000 micromoles per 48 hours with greater than 4% primary bile acids in stool, or

4. greater than 10% primary bile acid (CA and CDCA) in stool 48 hour collection, or

5. serum 7 alpha C4 greater than 52 ng/mL

6. BMI <40 kg/m2.

7. Prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study.

8. Participants receiving bile acid sequestrant will not be permitted to continue therapy. and need to stop one week before baseline test.

9. No use of oral antibiotics and NSAIDs for 2 weeks prior to study treatment

Exclusion criteria

1. Diabetes mellitus (type 1)

2. Diabetes mellitus type 2 if taking metformin or GLP-1 agonist treatment (exenatide, liraglutide, semaglutide)

3. Uncontrolled hypertension (with BP measured >140/90mmHg in the CRTU)

4. BMI ≥40 kg/m2

5. Chronic NSAID use (>1 day/week)

6. Use of oral antibiotics and NSAIDs for 2 weeks prior to and during the entire 21 day study period

7. Use of bile acid sequestrant for 1 week prior to and during the entire 21 day study period

8. 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;

9. Prior intestinal or colonic resection; note prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study

10. Participation in highly vigorous exercise such as running >5 miles per day in week prior to the permeability test

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Minnesota	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Michael Camilleri, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Michael Camilleri, MD, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT06028035
• Other Study ID Numbers: 23-005827
• First Posted: Sep 7, 2023
• Last Update Posted: Sep 7, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Irritable Bowel Syndrome; Diarrhea

Study Results

No Results Posted as of Sep 7, 2023