Reducing Intestinal Permeability with Hemp Hull WFI in IBS-Diarrhea With Evidence of Bile Acid Diarrhea
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-005827
NCT ID: NCT06028035
About this study
The purpose of this study is to demonstrate reduced intestinal permeability after 3 weeks of BB01 (20g of BB01, which reflects 15g of insoluble dietary fiber) consumption in a group of 10 patients with IBS-diarrhea with evidence of bile acid diarrhea, a group that has been previously documented to have increased GI permeability.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
- Age 18-70 years old.
- BMI <40 kg/m^2.
- 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.
- No use of oral antibiotics and NSAIDs for 2 weeks prior to study treatment.
Exclusion criteria
- Diabetes mellitus (type 1).
- Diabetes mellitus type 2 if taking metformin or GLP-1 agonist treatment (exenatide, liraglutide, semaglutide).
- Uncontrolled hypertension (with BP measured > 140/90mmHg in the CRTU).
- BMI ≥ 40 kg/m^2
- Chronic NSAID use (>1 day/week).
- Use of oral antibiotics and NSAIDs for 2 weeks prior to and during the entire 28 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.
- Prior intestinal or colonic resection; note prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study.
- Participation in highly vigorous exercise such as running >5 miles per day in week prior to the permeability test.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 6/6/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available