protocolSection identificationModule nctId: NCT06351124, orgStudyIdInfo id: 00005294, briefTitle: Beta-Hydroxybutyrate Feasibility Treating IBS, acronym: BHB, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Texas at Austin, class: OTHER, descriptionModule briefSummary: This clinical trial aims to understand the feasibility of patients taking ketone body supplement beta-hydroxybutyrate (BHB) for 4 weeks with a confirmed diagnosis of Crohn's disease and starting new therapy for active disease.The main questions it aims to answer are:* BHB supplementation will be feasible and acceptable to patients.* BHB supplementation will be associated with a reduction in systemic inflammation.* BHB supplementation will be associated with a reduction in pro-inflammatory bacterial colonies.Participants will:* Take 3 capsules x 3 times per day for 4 weeks.* Document food consumption using a 24-hour food recall questionnaire.* Provide blood and fecal samples twice, at the beginning of the study and the 4-week mark.Researchers will compare the group taking the ketone body supplement and the group not taking the supplement to see if the supplement provides relief of symptoms suffered from Crohn's disease., conditionsModule conditions: Crohn's Disease, conditions: Irritable Bowel Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This will be a prospective, open-label, randomized, two-arm pilot trial of adults, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: Eligible consenting patients will be randomized to either standard of care therapy (control) vs standard of care therapy plus BHB supplementation (intervention). BHB will be supplemented as a capsule taken orally three times daily for four weeks for those randomized to the intervention arm., enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Inflammatory Bowel Disease, outcomesModule primaryOutcomes measure: Ability to enroll patients who meet the inclusion criteria within the target time frame, primaryOutcomes measure: Adherence to proposed study timelines and anticipated study costs, primaryOutcomes measure: Patient adherence to the intervention, secondaryOutcomes measure: Microbial Diversity, secondaryOutcomes measure: BHB Blood Levels, secondaryOutcomes measure: Gastrointestinal Symptoms, secondaryOutcomes measure: Quality of Life, secondaryOutcomes measure: Clinical Response, secondaryOutcomes measure: Systemic Inflammation, secondaryOutcomes measure: Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Texas at Austin, city: Austin, state: Texas, zip: 78712, country: United States, contacts name: Michelle Stickler, Associate Vice President, DEd, role: CONTACT, phone: 512-475-6323, email: m.stickler@austin.utexas.edu, contacts name: Thomas Street, Executive Director, role: CONTACT, phone: 512 495 5142, email: thomas.street@austin.utexas.edu, geoPoint lat: 30.26715, lon: -97.74306, hasResults: False