What side effects are associated with this type of intervention?

Common treatments for Irritable Bowel Syndrome (IBS) include dietary fiber supplements, such as those containing insoluble fiber from sources like hemp hulls, and medications like alosetron. Dietary fiber can improve stool consistency and bowel regularity but may cause bloating and gas in some individuals. Alosetron, a 5-HT3 receptor antagonist, is effective in reducing IBS symptoms but is associated with side effects such as constipation, which can be mild to moderate, and in rare cases, ischemic colitis. Bile acid sequestrants, used for IBS-D, can cause gastrointestinal side effects including bloating, flatulence, and abdominal discomfort.

What prior FDA approvals exist?

The FDA has approved several treatments for Irritable Bowel Syndrome (IBS), particularly for IBS with diarrhea (IBS-D). Alosetron hydrochloride (Lotronex) is a 5-HT3 receptor antagonist approved for women with severe IBS-D, which helps reduce bowel urgency and abdominal pain but may cause constipation. Another treatment, eluxadoline, is approved for IBS-D and works by modulating opioid receptors to reduce bowel contractions, though it carries risks such as pancreatitis. While these treatments focus on symptom relief, the study bar with insoluble dietary fiber from hemp hulls aims to improve gut barrier function and bowel regularity, offering a different approach by potentially addressing the underlying intestinal permeability issues in IBS-D patients.

What other types of research exist?

Promising novel alternatives for IBS patients in 2024 include: 1) Guanylate cyclase agonists like linaclotide and plecanatide, which stimulate intestinal fluid secretion and transit. 2) Probiotics, particularly Lactobacillus reuteri, which have shown efficacy in managing gut health. 3) Elemental diets, which can induce remission of symptoms in patients with SIBO. 4) Personalized dietary modifications, such as low FODMAP diets, which can help manage IBS symptoms effectively.

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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:

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

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I regularly use NSAIDs more than once a week.

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

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 weeks for reporting.

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

0 / 4Eligibility criteria met

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.