Hemp Hull WFI for IBS Diarrhea

Overseen By Irene Busciglio

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Metformin, GLP-1 agonists, NSAIDs

Disqualifiers: Diabetes, Hypertension, BMI ≥40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a special fiber bar made from hemp seed shells on people with a type of irritable bowel syndrome that causes diarrhea. The goal is to see if the bar can make their intestines stronger and less 'leaky,' improving their digestion.

Will I have to stop taking my current medications?

If you are taking bile acid sequestrants, you will need to stop one week before the study begins and not use them during the study. Also, you cannot use oral antibiotics or NSAIDs for two weeks before and during the study.

Is Hemp Hull WFI safe for human use?

A study on full spectrum hemp extract products, similar to Hemp Hull WFI, found that they are generally safe and well tolerated, with only a small percentage of users reporting mild side effects like stomach discomfort or skin rashes. No serious liver issues were reported, suggesting a good safety profile at recommended doses. ^{1 2 3 4 5}

How does the treatment Hemp Hull WFI differ from other treatments for IBS-D?

Hemp Hull WFI is unique because it is derived from hemp, which may offer a novel approach compared to traditional IBS-D treatments that often focus on dietary changes or pharmaceuticals. While the exact mechanism for IBS-D is not detailed, hemp-based treatments are generally known for their potential anti-inflammatory and gut health benefits, which could provide a different therapeutic pathway. ^{1 3 6 7 8}

Research Team

Michael Camilleri, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals with IBS-diarrhea who have specific bile acid levels in their blood and stool, a BMI under 40, and haven't used antibiotics or NSAIDs recently. Those with certain surgeries like gallbladder removal can join, but not if they've had other bowel surgeries or take certain diabetes medications.

Inclusion Criteria

Your primary bile acid (CA and CDCA) content in a 48-hour stool sample must exceed 10%.

BMI <40 kg/m2

Your serum 7 alpha C4 is over 52 ng/mL.

Exclusion Criteria

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

I have type 2 diabetes and am on metformin or GLP-1 agonists.

I have been diagnosed with an inflammatory gastrointestinal disease or had a GI infection in the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume two BB01 supplement bars daily for 21 days

3 weeks

Baseline and end of treatment visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

Treatment Details

Interventions

• Hemp Hull WFI

Trial Overview The study is testing the effects of a bar containing hemp hull-derived dietary fiber on gut health in people with IBS-diarrhea. The focus is on how this fiber affects intestinal permeability—a measure of how easily substances pass through the gut lining.

Participant Groups

Group I: BB01 Supplement Bars Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of Hemp seed soft capsule on colonic ion transport in rats. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Post Marketing Safety of Plus CBD™ Products, a Full Spectrum Hemp Extract: A 2-Year Experience. [2021]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Why Use Nutraceutical Strategies for the Irritable Bowel Syndrome? [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Charcoal tablets in the treatment of patients with irritable bowel syndrome. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: the analgesic properties of dietary supplementation with palmitoylethanolamide and polydatin in irritable bowel syndrome. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Low-FODMAP Diet Improves the Global Symptoms and Bowel Habits of Adult IBS Patients: A Systematic Review and Meta-Analysis. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Usefulness of the Low-FODMAP Diet with Limited Tryptophan Intake in the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Beneficial Effects on Abdominal Bloating with an Innovative Food-Grade Formulation of Curcuma longa and Boswellia serrata Extracts in Subjects with Irritable Bowel Syndrome and Small Bowel Dysbiosis. [2023]