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Dietary Supplement

Hemp Hull WFI for IBS Diarrhea

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 weeks

Awards & highlights

Study Summary

This trial will test if a study bar containing hemp can help people with IBS-bile acid diarrhea reduce their symptoms.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in urinary excretion of 13^C-mannitol

Change in urinary excretion of lactulose

Trial Design

1Treatment groups

Experimental Treatment

Group I: BB01 Supplement BarsExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,478 Total Patients Enrolled

23 Trials studying Irritable Bowel Syndrome

1,151 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for enrolling in this trial above sixty years?

"To partake in this medical trial, individuals must be aged 18 or older and under 70."

Answered by AI

Are there still patient slots available to participate in this investigation?

"As per the latest data hosted on clinicaltrials.gov, enrollment for this trial has closed since its last update in September 18th 2023. This notwithstanding, there are still 178 different studies actively looking for participants at present."

Answered by AI

Do I qualify for inclusion in this investigational research?

"In order to be eligible for the trial, individuals must possess a diagnosis of irritable bowel syndrome and fall between 18-70 years old. Moreover, 10 persons are required to participate in this endeavour."

Answered by AI