A Study of Hemp Hull WFI for IBS Diarrhea (NCT06028035) | Clinical Trial Compass
CompletedNot Applicable
A Study of Hemp Hull WFI for IBS Diarrhea
United States10 participantsStarted 2023-10-06
Plain-language summary
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, on intestinal permeability in irritable bowel syndrome (IBS)-bile acid diarrhea individuals.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Prior diagnosis of bile acid diarrhea as documented by either
. total bile acid in 48 hour stool excretion of 2337 micromoles per 48 hours, or
. greater than 1000 micromoles per 48 hours with greater than 4% primary bile acids in stool, or
. greater than 10% primary bile acid (CA and CDCA) in stool 48 hour collection, or
. serum 7 alpha C4 greater than 52 ng/mL
. BMI \<40 kg/m2.
. Prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study.
. Participants receiving bile acid sequestrant will not be permitted to continue therapy. and need to stop one week before baseline test.
Exclusion criteria
. Diabetes mellitus (type 1)
. Diabetes mellitus type 2 if taking metformin or GLP-1 agonist treatment (exenatide, liraglutide, semaglutide)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Uncontrolled hypertension (with BP measured \>140/90mmHg in the CRTU)
. BMI ≥40 kg/m2
. Chronic NSAID use (\>1 day/week)
. Use of oral antibiotics and NSAIDs for 2 weeks prior to and during the entire 21 day study period
. Use of bile acid sequestrant for 1 week prior to and during the entire 21 day study period
. Diagnosis of gastrointestinal diseases that are associated with inflammation such as inflammatory bowel diseases and celiac disease or gastrointestinal infection in the prior 4 weeks;