Crohn's Disease · Inflammatory Bowel Diseases
Beta-hydroxybutyrate Supplement Study for Adults With Active Crohn’s Disease
This pilot study examines whether four weeks of beta-hydroxybutyrate supplementation is feasible and acceptable and how it relates to inflammation, gut bacteria, symptoms, and disease activity in adults starting new therapy for active Crohn’s disease.
Registry title: Beta-Hydroxybutyrate Feasibility Treating IBD
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's
- Design
- Randomized
- Central study contact
- Linda A. Feagins, Associate Professor, MD512-495-5641linda.feagins@austin.utexas.edu
- Sponsor
- University of Texas at Austin
Research question
Is four weeks of beta-hydroxybutyrate supplementation feasible and acceptable for adults starting new Crohn’s disease therapy, and is supplementation associated with changes in inflammation, gut bacteria, symptoms, and disease severity?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older with a confirmed Crohn’s disease diagnosis.
- Participants must have active disease shown by fecal calprotectin above 250 µg/g or active disease on endoscopy within the previous three months.
- Participants must be starting a listed biologic or small-molecule therapy for active disease.
- Participants must be managed at the University of Texas Digestive Health Clinic.
Participation overview
What participation may involve
Participants continue standard-of-care therapy and are randomized either to receive no BHB supplement or to add BHB capsules for four weeks. The study collects dietary information, samples, symptom measures, disease-activity measures, and adverse-event information. What participation may involve: - Participants assigned to BHB take three capsules three times per day for four weeks. - Participants document food consumption with a 24-hour food-recall questionnaire. - Participants provide blood and fecal samples at the beginning of the study and at four weeks. - Study assessments include gastrointestinal symptoms, broader patient-reported health measures, inflammatory markers, microbial diversity, disease activity, and adverse events. - Disease activity is assessed with intestinal ultrasound at four weeks. The participant-facing supplementation and assessment period described in the registry lasts four weeks.
Study interventions
What participants may receive or do
- Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's: Participants assigned to the intervention arm take beta-hydroxybutyrate (BHB) capsules by mouth three times daily for four weeks in addition to standard-of-care therapy.
Study design
How the comparison works
This is an open-label, randomized, parallel-group pilot study. Adults are assigned to standard-of-care therapy alone or standard-of-care therapy plus beta-hydroxybutyrate supplementation. Participants are randomly assigned to one of two study arms. The study is open-label with no masking, so participants and researchers know which arm a participant enters. The control arm receives standard-of-care therapy without the beta-hydroxybutyrate supplement. The registry describes no placebo or sham intervention; the comparison is standard care without the supplement.
Reported activities
Procedures and tests
- A 24-hour food-recall questionnaire records food consumption.
- Blood samples are collected at baseline and four weeks.
- Fecal samples are collected at baseline and four weeks.
- Fecal samples are used to assess microbial diversity and the proportional abundance of major bacterial groups.
- Blood beta-hydroxybutyrate levels are compared between baseline and four weeks.
- Gastrointestinal symptoms are assessed with a GI PROMIS score.
- PROMIS-29 measures pain intensity and several areas of physical, emotional, and social health.
- Fecal calprotectin is used to assess change in disease activity.
- C-reactive protein is measured as a marker of systemic inflammation.
- Adverse events related to the intervention are assessed at four weeks.
- Intestinal ultrasound is used to assess inflammatory bowel disease activity without bowel preparation, fasting, or sedation.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be at least 18 years old.
- A confirmed diagnosis of Crohn’s disease is required.
- Active disease must be shown by fecal calprotectin above 250 µg/g or by active disease on endoscopy within the previous three months.
- Participants must be starting a new biologic or small-molecule therapy from the categories listed by the registry.
- Participants must be managed at the University of Texas Digestive Health Clinic.
- Participants must be willing to provide consent.
Possible reasons someone may not be able to join
- Current BHB supplement use, or use within the previous four weeks, is not allowed.
- Following a ketogenic diet now or within the previous four weeks is exclusionary.
- Following an intermittent-fasting diet now or within the previous four weeks is exclusionary.
- Antibiotic use within the previous three months is exclusionary.
- Clostridioides difficile infection within the previous six months is exclusionary.
- Daily proton-pump inhibitor or H2-receptor blocker use now or within the previous four weeks is exclusionary.
- Use of non-dietary probiotic supplements now or within the previous four weeks is exclusionary.
- People unwilling to provide signed consent cannot participate.
Important unknowns
What the record does not make clear
- The registry identifies baseline and four-week sample collection but does not provide the complete number, timing, length, or format of study visits.
- Both arms receive standard-of-care therapy, and participants must be starting a new listed therapy, but the registry does not explain how that treatment is selected, timed, or managed during the study.
- The criteria exclude several recent supplements, diets, and medications, but the registry does not say whether stopping any of them for enrollment is permitted or medically appropriate.
- The registry does not describe how worsening Crohn’s disease would be treated during the study or whether rescue treatment affects continued participation.
- A recent endoscopy can document active disease for screening, but the registry does not state that a new study endoscopy is required.
- The registry does not distinguish research-covered services from routine-care charges or explain possible insurance billing.
- The registry does not state whether participants are compensated.
- The registry does not describe reimbursement or other support for travel to the Austin site.
- The registry does not say whether any visits, questionnaires, or sample collection can be completed remotely.
- The registry does not explain whether BHB is available through the study after the four-week period.
- The Austin location is listed as recruiting, but the registry status was last verified in September 2024, so current openings require confirmation.
Before contacting the site
Questions for the study team
- How many visits are required, which must be in person, and how long does each usually take?
- How is the new standard-of-care Crohn’s therapy chosen and timed relative to randomization and BHB supplementation?
- What side effects or risks of BHB are discussed during consent, and how are adverse events monitored between baseline and week four?
- Would screening require a new endoscopy, fecal calprotectin test, blood test, or stool sample?
- What happens if Crohn’s symptoms or inflammation worsen during the study?
- Which study-related services are covered, what may be billed to insurance, and is compensation or travel reimbursement available?
- Is the Austin site currently enrolling, and how soon after starting a new Crohn’s therapy must study activities begin?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease now, and would delaying or coordinating study screening with the start of a new therapy affect my care?
- How should my current medicines, acid-suppressing therapy, probiotics, supplements, diet, or recent antibiotics be handled while I explore this study?
- What approved treatment alternatives are appropriate for my current disease activity, independent of this study?
- Are there risks or monitoring concerns with adding BHB to the specific Crohn’s therapy and other medicines I use?
- How should my gastroenterology team and the research team coordinate laboratory results, ultrasound findings, symptom changes, and treatment decisions?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
A clinical trial designed to determine the feasibility of prebiotic supplementation with beta-hydroxybutyrate (BHB) in Crohn's patients in a prospective, open-label pilot trial and to assess the association between BHB supplementation and changes in the microbiome, inflammation, and markers of disease severity in Crohn's patients in a prospective pre-/post-study design.
Study design and administration
- Organization
- University of Texas at Austin
- Organization class
- Other
- Organization study ID
- 00005294
- Lead sponsor
- University of Texas at Austin
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Supportive Care
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
No Intervention
standard of care therapy (control)
Arm does not receive the BHB supplement
Active Comparator
Standard of care therapy plus BHB supplementation (intervention).
Arm does receives the BHB supplement
Interventions: Biological: Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's
Interventions
Biological
Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's
Is Beta-hydroxybutyrate a supplement that can control symptoms and progression of Crohn's.
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (6)
- Age ≥18 years of ageRegistry-derived · unreviewed
- Confirmed diagnosis of Crohn's diseaseRegistry-derived · unreviewed
- Active disease defined as either a fecal calprotectin \>250 µg/g or active disease on endoscopy within the prior 3 monthsRegistry-derived · unreviewed
- Starting a new therapy defined as a biologic (anti-TNF, anti-integrin, IL-12/23, or IL-23) or small molecule therapy (JAK inhibitor, S1P receptor modulator)Registry-derived · unreviewed
- Willing to provide consent for participation.Registry-derived · unreviewed
- Managed at UT Digestive Health Clinic.Registry-derived · unreviewed
Exclusion criteria (8)
- Any current or recent (within 4 weeks) use of BHB supplementRegistry-derived · unreviewed
- Currently or recently (within 4 weeks) following a ketogenic dietRegistry-derived · unreviewed
- Currently or recently (within 4 weeks) following an intermittent fasting dietRegistry-derived · unreviewed
- Any recent antibiotic use (within 3 months)Registry-derived · unreviewed
- Recent infection with C. difficile (within 6 months)Registry-derived · unreviewed
- Current or recent (within 4 weeks) daily use of acid-suppressing therapy (proton pump inhibitor or H2 receptor blocker)Registry-derived · unreviewed
- Current or recent use (within four weeks) of non-dietary probiotic supplementsRegistry-derived · unreviewed
- Unwilling to provide signed consentRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Ability to enroll patients who meet the inclusion criteria within the target time frame
Time frame: 12 months
Number of patients recruited
Primary outcome
Adherence to proposed study timelines and anticipated study costs
Time frame: 12 months
Alignment of predicted timeline and costs to real timeline and costs
Primary outcome
Patient adherence to the intervention
Time frame: 12 months
How many dosages do participants miss following the regiment.
Secondary outcome
Microbial Diversity
Time frame: 4 weeks
Changes in the microbial diversity and proportional abundance of major bacterial taxa at four weeks compared to baseline
Secondary outcome
BHB Blood Levels
Time frame: 4 weeks
Changes in BHB serum levels at baseline compared to 4 weeks
Secondary outcome
Gastrointestinal Symptoms
Time frame: 4 weeks
Changes in (GI PROMIS score)
Secondary outcome
Pain intensity (Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: 4 weeks
Changes in (PROMIS-29), PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. Scales: Physical Function 5-1: 5.without any difficulty, 4.with a little difficulty, 3.with some difficulty, 2.with much difficulty, 1.unable Anxiety \& Depression 1-5: 1.Never, 2.Rarely, 3.Sometimes, 4.Often, 5.Always Fatigue 5-1: 1.Not at all, 2.A little bit, 3.Somewhat, 2.Quite a bit, 1.Very much Sleep Disturbance 5-1: 5.Very poor, 4.poor 3. fair, 2.Good, 1. very good Ability to participate in social roles and activities 5-1: 5.Never, 4.Rarely, 3.Sometimes, 2.Usually, 1.Always Pain interference 1-5: 1. Not at all, 2.A little bit, 3.Somewhat, 4.Quite a bit, 5.Very much
Secondary outcome
Clinical Response
Time frame: 4 weeks
Improved disease activity (reduction in fecal calprotectin by 50%)
Secondary outcome
Systemic Inflammation
Time frame: 4 weeks
changes measured by C-reactive protein
Secondary outcome
Adverse Events
Time frame: 4 weeks
Adverse events related to the intervention. Outcomes will be assessed at four weeks follow-up
Secondary outcome
Assess disease activity by Intestinal Ultrasound (IUS)
Time frame: 4 weeks
Assess disease activity in patients with inflammatory bowel disease using Intestinal ultrasound (IUS), a noninvasive tool. This can be performed in the clinic at the bedside without any bowel preparation, fasting, or sedation. It is highly acceptable to patients with minimal risk.
Recruiting locations in the United States
University of Texas at Austin
RecruitingAustin, Texas, 78712, United States
Michelle Stickler, Associate Vice President, DEd512-475-6323m.stickler@austin.utexas.edu
Thomas Street, Executive Director512 495 5142thomas.street@austin.utexas.edu
Central study contacts
Registry dates
- First posted
- Apr 8, 2024
- Primary completion
- Apr 1, 2025
- Overall completion
- Dec 31, 2025
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.