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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a fiber bar made from hemp hulls affects individuals with irritable bowel syndrome (IBS) and bile acid-induced diarrhea. The researchers aim to determine if consuming two bars daily for 21 days can alleviate symptoms by altering intestinal function. Suitable participants have been diagnosed with bile acid diarrhea and are not currently using medications such as bile acid sequestrants or specific antibiotics.

As an unphased trial, this study provides a unique opportunity to explore a new dietary approach for symptom management.

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.

What prior data suggests that Hemp Hull WFI is safe for IBS diarrhea?

Research shows that hemp use usually doesn't cause stomach problems like diarrhea. Some studies suggest that hemp hull fiber might help with gut issues in people with IBS-related diarrhea. Although detailed safety information about Hemp Hull WFI is limited, the ongoing research into hemp hulls suggests they are generally considered safe. As this treatment involves a fiber supplement, it may be similar to other dietary fibers, which most people can usually tolerate easily. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for IBS diarrhea, which often rely on medications that manage symptoms or alter gut motility, Hemp Hull WFI is derived from hemp hulls. This gives it a unique edge as it introduces a new, natural active ingredient that may offer a gentler alternative with potentially fewer side effects. Researchers are excited about this treatment because it introduces a novel dietary approach, using BB01 supplement bars, that could offer relief by supporting gut health in a holistic way. If effective, it might provide a more sustainable, lifestyle-friendly option for managing IBS symptoms.

What evidence suggests that Hemp Hull WFI might be an effective treatment for IBS diarrhea?

Research has shown that hemp hulls, rich in a type of fiber that doesn't dissolve in water, might help with diarrhea caused by IBS. A small study found that this fiber can reduce gut "leakiness," a common issue in IBS. This fiber adds bulk to stools and can regulate bowel movements, potentially easing diarrhea. Additionally, hemp extracts like CBD can interact with the gut to alter its movement, possibly aiding with diarrhea. These early findings suggest that hemp hulls could benefit people with IBS-related diarrhea. Participants in this trial will consume BB01 supplement bars containing Hemp Hull WFI to evaluate its effectiveness for IBS-related diarrhea. ^{1 2 6 7 8}

Who Is on the Research Team?

Michael Camilleri, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39031892/

A pilot study of hemp hull bio gut fibre (BGF) to reduce ...

Letter (brief communication): A pilot study of hemp hull bio gut fibre (BGF) to reduce intestinal permeability in IBS-BAD.

2.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06028035/a-study-of-hemp-hull-wfi-for-ibs-diarrhea

A Study of Hemp Hull WFI for IBS Diarrhea

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, ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10490209/

Outcome-Specific Efficacy of Different Probiotic Strains and ...

Four probiotic strains and a mixture were significantly superior to placebo in reducing the bowel movement frequency in diarrhea-predominant ...

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malacards.org

malacards.org/card/diarrhea

Diarrhea

Integrated disease information for Diarrhea including associated genes, mutations, phenotypes, pathways, drugs, and more - integrated from 78 data sources.

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indiahemporganics.com

indiahemporganics.com/blogs/food-blog/benefits-of-adding-hemp-to-your-ibs-diet-plan?srsltid=AfmBOopsqcPxkEs9PzBG3CPN9WYXpzbiHEweZO_b65gRgPot6FkIVd3y

Benefits Of Adding Hemp To Your IBS Diet Plan

Hemp extracts, such as CBD, bind to receptors in the EDS to change the way movement occurs in the gut. This relieves the IBS symptoms of diarrhea. In fact, the ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12113862/

Irritable Bowel Syndrome with Diarrhea (IBS-D)

These findings support the C. butyricum CBM588 probiotic strain as a safe, well-tolerated, and microbiota-targeted intervention for IBS-D. Randomized controlled ...

7.

malacards.org

malacards.org/card/irritable_bowel_syndrome

Irritable Bowel Syndrome (IBS)

Integrated disease information for Irritable Bowel Syndrome including associated genes, mutations, phenotypes, pathways, drugs, and more - integrated from ...

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consensus.app

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Can hemp use cause gastrointestinal discomfort such as ...

... hemp use directly causes gastrointestinal discomfort such as diarrhea. There is no strong evidence in the provided research that hemp use commonly causes ...