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Dietary Supplement
Hemp Hull WFI for IBS Diarrhea
N/A
Waitlist Available
Led By Michael Camilleri, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Diabetes mellitus type 2 if taking metformin or GLP-1 agonist treatment (exenatide, liraglutide, semaglutide)
Chronic NSAID use (>1 day/week)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 weeks
Awards & highlights
No Placebo-Only Group
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not explicitly listed here, but generally, high-fiber products may cause bloating, gas, or changes in bowel habits as your body adjusts to increased fiber intake.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have type 2 diabetes and am on metformin or GLP-1 agonists.
Select...
I regularly use NSAIDs more than once a week.
Select...
I have been diagnosed with an inflammatory gastrointestinal disease or had a GI infection in the last 4 weeks.
Select...
I have type 1 diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in urinary excretion of 13^C-mannitol
Change in urinary excretion of lactulose
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: BB01 Supplement BarsExperimental Treatment1 Intervention
Subjects will consume two BB01 supplement bars daily for 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BB01
2023
N/A
~10
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Irritable Bowel Syndrome (IBS) include dietary modifications and medications that target specific symptoms. Insoluble dietary fiber, such as that found in hemp hulls, adds bulk to the stool and improves bowel regularity, which is beneficial for patients with diarrhea-predominant IBS (IBS-D).
This fiber also enhances gut barrier function, potentially reducing intestinal permeability and inflammation. Low FODMAP diets help by reducing the intake of fermentable carbohydrates that can cause bloating and discomfort.
Medications like alosetron modulate serotonin receptors to reduce bowel urgency and abdominal pain. These treatments are essential for IBS patients as they address the underlying mechanisms of symptom generation, providing relief and improving quality of life.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,353 Previous Clinical Trials
3,061,013 Total Patients Enrolled
26 Trials studying Irritable Bowel Syndrome
5,173 Patients Enrolled for Irritable Bowel Syndrome
Michael Camilleri, MDPrincipal InvestigatorMayo Clinic
38 Previous Clinical Trials
3,262 Total Patients Enrolled
9 Trials studying Irritable Bowel Syndrome
335 Patients Enrolled for Irritable Bowel Syndrome