Crohn's DiseasePhase 1/2BHBNCT06351124
Beta-Hydroxybutyrate Feasibility Treating IBD
A Phase 1/2 study testing Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's in people with Crohn's Disease and Inflammatory Bowel Diseases, run by University of Texas at Austin at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Inflammatory Bowel Diseases
- What is being tested?
- Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2024to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years of age
- Confirmed diagnosis of Crohn's disease
- Active disease defined as either a fecal calprotectin \>250 µg/g or active disease on endoscopy within the prior 3 months
- 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)
- Willing to provide consent for participation.
- Managed at UT Digestive Health Clinic.
Who cannot join
- Any current or recent (within 4 weeks) use of BHB supplement
- Currently or recently (within 4 weeks) following a ketogenic diet
- Currently or recently (within 4 weeks) following an intermittent fasting diet
- Any recent antibiotic use (within 3 months)
- Recent infection with C. difficile (within 6 months)
- Current or recent (within 4 weeks) daily use of acid-suppressing therapy (proton pump inhibitor or H2 receptor blocker)
- Current or recent use (within four weeks) of non-dietary probiotic supplements
- Unwilling to provide signed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Texas at Austin
Austin, Texas, 78712
Michelle Stickler, Associate Vice President, DEd, 512-475-6323, m.stickler@austin.utexas.edu
Thomas Street, Executive Director, 512 495 5142, thomas.street@austin.utexas.edu
About this study
Official title: Feasibility of Beta-hydroxybutyrate Supplementation to Reduce Inflammation in Patients with Inflammatory Bowel Disease
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Crohn's Disease, Inflammatory Bowel Diseases
- Being tested
- Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's
- Keywords
- Beta-hydroxybutyrate (BHB), proinflammatory immune cells, gut bacteria, ketone body, ketogenesis, gut barrier integrity, inflammation, digestive health
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn'sBiological
Also called BHB Feasibility
Is Beta-hydroxybutyrate a supplement that can control symptoms and progression of Crohn's.
| Study group | Role | What they receive |
|---|---|---|
| standard of care therapy (control) | No intervention | Arm does not receive the BHB supplement |
| Standard of care therapy plus BHB supplementation (intervention). | Active comparator | Arm does receives the BHB supplement Receives: Biological: Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to enroll patients who meet the inclusion criteria within the target time frame
Number of patients recruited
Measured: 12 months
Adherence to proposed study timelines and anticipated study costs
Alignment of predicted timeline and costs to real timeline and costs
Measured: 12 months
Patient adherence to the intervention
How many dosages do participants miss following the regiment.
Measured: 12 months
Secondary outcomes (8)
Microbial Diversity
Changes in the microbial diversity and proportional abundance of major bacterial taxa at four weeks compared to baseline
Measured: 4 weeks
BHB Blood Levels
Changes in BHB serum levels at baseline compared to 4 weeks
Measured: 4 weeks
Gastrointestinal Symptoms
Changes in (GI PROMIS score)
Measured: 4 weeks
Pain intensity (Patient-Reported Outcomes Measurement Information System (PROMIS)
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
Measured: 4 weeks
Clinical Response
Improved disease activity (reduction in fecal calprotectin by 50%)
Measured: 4 weeks
Systemic Inflammation
changes measured by C-reactive protein
Measured: 4 weeks
Adverse Events
Adverse events related to the intervention. Outcomes will be assessed at four weeks follow-up
Measured: 4 weeks
Assess disease activity by Intestinal Ultrasound (IUS)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start28 Aug 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a prospective, open-label, randomized, two-arm pilot trial of adults
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda A. Feagins, Associate Professor, MD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351124
- Sponsor's protocol ID
- 00005294
- Acronym
- BHB
- Status last verified
- Sep 2024
- First submitted
- 26 Mar 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Beta-hydroxybutyrate Supplementation to Reduce Inflammation in Patients with Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06351124
- Acronym / sponsor ID
- BHB / 00005294
- Conditions
- Crohn's Disease, Inflammatory Bowel Diseases
- Keywords
- Beta-hydroxybutyrate (BHB), proinflammatory immune cells, gut bacteria, ketone body, ketogenesis, gut barrier integrity, inflammation, digestive health
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a prospective, open-label, randomized, two-arm pilot trial of adults
| Arm | Type | Receives |
|---|---|---|
| standard of care therapy (control) | No intervention | –Arm does not receive the BHB supplement |
| Standard of care therapy plus BHB supplementation (intervention). | Active comparator | Biological: Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn'sArm does receives the BHB supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years of age
- Confirmed diagnosis of Crohn's disease
- Active disease defined as either a fecal calprotectin \>250 µg/g or active disease on endoscopy within the prior 3 months
- 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)
- Willing to provide consent for participation.
Key exclusion criteria (8 listed)
- Any current or recent (within 4 weeks) use of BHB supplement
- Currently or recently (within 4 weeks) following a ketogenic diet
- Currently or recently (within 4 weeks) following an intermittent fasting diet
- Any recent antibiotic use (within 3 months)
- Recent infection with C. difficile (within 6 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn'sAlso: BHB FeasibilityIs Beta-hydroxybutyrate a supplement that can control symptoms and progression of Crohn's. | Biological | Standard of care therapy plus BHB supplementation (intervention). |
Primary outcome
Ability to enroll patients who meet the inclusion criteria within the target time frame
Time frame: 12 months
Number of patients recruited
Adherence to proposed study timelines and anticipated study costs
Time frame: 12 months
Alignment of predicted timeline and costs to real timeline and costs
Patient adherence to the intervention
Time frame: 12 months
How many dosages do participants miss following the regiment.
8 secondary outcomes
Microbial Diversity
Time frame: 4 weeks
BHB Blood Levels
Time frame: 4 weeks
Gastrointestinal Symptoms
Time frame: 4 weeks
Pain intensity (Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: 4 weeks
Clinical Response
Time frame: 4 weeks
Systemic Inflammation
Time frame: 4 weeks
Adverse Events
Time frame: 4 weeks
Assess disease activity by Intestinal Ultrasound (IUS)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda A. Feagins, Associate Professor, MD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Crohn's in people with Crohn's Disease and Inflammatory Bowel Diseases, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda A. Feagins, Associate Professor, MD (512-495-5641, linda.feagins@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to enroll patients who meet the inclusion criteria within the target time frame (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.