Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-28 @ 10:40 PM
Study NCT ID:
NCT06028035
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2023-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Hemp Hull WFI for IBS Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2023-08-31', 'studyFirstSubmitQcDate': '2023-08-31', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in urinary excretion of 13^C-mannitol', 'timeFrame': 'Baseline, 3 weeks', 'description': 'Percent urinary excretion of 13\\^C-mannitol'}, {'measure': 'Change in urinary excretion of lactulose', 'timeFrame': 'Baseline, 3 weeks', 'description': 'Percent urinary excretion of lactulose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome-bile Acid Diarrhea']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Patients with irritable bowel syndrome-bile acid diarrhea (IBS-BAD) have no evidence of significant histologically-evident inflammation or ulceration. The condition is often unrecognized in comparison with natural variations in bowel function in the general population. Hemp seeds are a complete source of protein, providing all nine essential amino acids, as well as polyunsaturated fats, especially omega-3 fatty acid, fiber, minerals and vitamins. Hemp hulls, the outer shell of the seeds, are typically rich in dietary fiber and phenolics and showed to have a beneficial effect on gut barrier function in vitro.\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Prior diagnosis of bile acid diarrhea as documented by either\n\n 1. total bile acid in 48 hour stool excretion of 2337 micromoles per 48 hours, or\n 2. greater than 1000 micromoles per 48 hours with greater than 4% primary bile acids in stool, or\n 3. greater than 10% primary bile acid (CA and CDCA) in stool 48 hour collection, or\n 4. serum 7 alpha C4 greater than 52 ng/mL\n2. BMI \\<40 kg/m2.\n3. Prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study.\n4. Participants receiving bile acid sequestrant will not be permitted to continue therapy. and need to stop one week before baseline test.\n5. No use of oral antibiotics and NSAIDs for 2 weeks prior to study treatment\n\nExclusion criteria\n\n1. Diabetes mellitus (type 1)\n2. Diabetes mellitus type 2 if taking metformin or GLP-1 agonist treatment (exenatide, liraglutide, semaglutide)\n3. Uncontrolled hypertension (with BP measured \\>140/90mmHg in the CRTU)\n4. BMI ≥40 kg/m2\n5. Chronic NSAID use (\\>1 day/week)\n6. Use of oral antibiotics and NSAIDs for 2 weeks prior to and during the entire 21 day study period\n7. Use of bile acid sequestrant for 1 week prior to and during the entire 21 day study period\n8. 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;\n9. Prior intestinal or colonic resection; note prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study\n10. Participation in highly vigorous exercise such as running \\>5 miles per day in week prior to the permeability test'}, 'identificationModule': {'nctId': 'NCT06028035', 'briefTitle': 'A Study of Hemp Hull WFI for IBS Diarrhea', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Pilot Study of Hemp Hull WFI (BB01) to Reduce Intestinal Permeability in IBS-Diarrhea With Evidence of Bile Acid Diarrhea', 'orgStudyIdInfo': {'id': '23-005827'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BB01 Supplement Bars', 'description': 'Subjects will consume two BB01 supplement bars daily for 21 days.', 'interventionNames': ['Dietary Supplement: BB01']}], 'interventions': [{'name': 'BB01', 'type': 'DIETARY_SUPPLEMENT', 'description': '20 grams minimally processed form of Hemp hulls in the form of a bar/wafer.', 'armGroupLabels': ['BB01 Supplement Bars']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Minnesota', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Michael Camilleri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Camilleri, MD', 'investigatorAffiliation': 'Mayo Clinic'}}}}