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Dietary Supplement

BHB Supplements for Adenomatous Polyposis (BHB-FAP Trial)

N/A

Recruiting

Led By Bryson W Katona, MD, PhD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have an extensive colonic resection with either a subtotal colectomy with ileorectal anastomosis (STC-IRA) or total proctocolectomy with ileal pouch anal anastomosis (TPC-IPAA)

Have at least two colorectal polyps (which can be present anywhere in the colon including the rectal cuff, or in the J-pouch [if applicable])

Must not have

Subject is pregnant, a prisoner, or is under 18 years of age

Prior total proctocolectomy with end ileostomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, which will be approximately 3 years

Summary

This trial aims to see if taking BHB supplements can help prevent the growth of intestinal adenomas in people with FAP. If successful, this could reduce the need for frequent medical procedures and possibly prevent

Who is the study for?

This trial is for adults with Familial Adenomatous Polyposis (FAP) who are scheduled for a colonoscopy or sigmoidoscopy. They must have had extensive colonic resection, at least two colorectal polyps, and a confirmed genetic diagnosis of FAP. Pregnant individuals, prisoners, minors, those on diabetes therapy or with inflammatory bowel disease, chronic kidney disease, large untreated polyps (>1cm), active cancer treatment or recent chemopreventive agent use cannot participate.

What is being tested?

The study tests if β-hydroxybutyrate (BHB) supplementation can prevent intestinal adenomas in FAP patients. Participants will receive different doses of R-1,3-Butanediol to deliver BHB or a placebo. The goal is to reduce the frequency of endoscopies/colonoscopies and possibly avoid surgery.

What are the potential side effects?

Potential side effects from BHB supplementation could include gastrointestinal discomforts such as nausea or stomach pain due to ketone body intake. Since this is an investigational study, there may be unknown risks associated with long-term BHB consumption.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had major surgery to remove parts of my colon.

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I have at least two polyps in my colon or rectal area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, imprisoned, or under 18.

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I have had surgery to remove my colon and rectum.

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I am currently undergoing treatment for my cancer.

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I have diabetes and am currently taking medication for it.

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I have a history of inflammatory bowel disease.

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My kidney function is reduced with an eGFR below 60.

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I have a polyp larger than 1 cm in my colon or small intestine that has not been removed.

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I haven't taken aspirin, NSAIDs, BHB supplements, or similar drugs regularly in the last 6 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, which will be approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, which will be approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, which will be approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine whether oral BHB supplementation is safe and tolerable in FAP

Secondary study objectives

Change in transcription and protein expression in the intestinal mucosa and in intestinal polyps in FAP after oral BHB supplementation

Determine whether oral BHB supplementation in FAP reduces intestinal polyp burden

Measure whether oral BHB supplementations increases serum BHB levels in FAP

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B - 20 gramsExperimental Treatment1 Intervention

Study participants will take one 35mL dose of HVMN Ketone-IQ by mouth twice per day (20 total grams of R-1,3-Butanediol) for 12 weeks

Group II: Part B - 10 gramsExperimental Treatment1 Intervention

Study participants will take one 35mL dose of HVMN Ketone-IQ by mouth per day along with one 35mL dose of placebo ketone drink by mouth per day (10 total grams of R-1,3-Butanediol) for 12 weeks

Group III: Part A - 30 gramsExperimental Treatment1 Intervention

Study participants will take three 35mL dose of HVMN Ketone-IQ by mouth per day (30 total grams of R-1,3-Butanediol) for 2 weeks

Group IV: Part A - 20 gramsExperimental Treatment1 Intervention

Study participants will take two 35mL dose of HVMN Ketone-IQ by mouth per day (20 total grams of R-1,3-Butanediol) for 2 weeks

Group V: Part A - 10 gramsExperimental Treatment1 Intervention

Study participants will take one 35mL dose of HVMN Ketone-IQ by mouth per day (10 total grams of R-1,3-Butanediol) for 2 weeks

Group VI: Part B - PlaceboPlacebo Group1 Intervention

Study participants will take one 35mL dose of placebo ketone drink by mouth twice daily for 12 weeks

0 / 10Eligibility criteria met