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Could a simple ketone drink reduce the need for surgery in FAP patients?

NCT ID NCT06578637

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This study tests whether a daily ketone supplement (BHB) is safe and tolerable for people with Familial Adenomatous Polyposis (FAP), a genetic condition that causes many colon polyps and often leads to surgery. Twenty participants will take the supplement for two weeks to see if it raises BHB levels in the blood and if it can eventually slow polyp growth. The goal is to reduce the need for frequent scopes and surgeries.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
R-1,3-Butanediol (a ketone supplement that raises blood BHB levels)
What this could lead to
If it works, this could point toward a daily supplement that helps control polyp growth in FAP, reducing the need for frequent colonoscopies and surgeries.
What could go wrong
This is a very early, small trial (20 people) testing safety and blood levels, not yet whether it actually prevents polyps. The supplement may cause side effects or not work as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Part A Inclusion Criteria: 1. Have a diagnosis of FAP with genetic testing demonstrating a pathogenic or likely pathogenic germline variant in APC, must have a clinical FAP phenotype with at least one member of the family who has a pathogenic or likely pathogenic germline variant in APC, or must have a clinical diagnosis of FAP as agreed by two gastrointestinal cancer genetics experts 2. 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) 3. Can provide informed consent Exclusion Criteria: 1. Subject is pregnant, a prisoner, or is under 18 years of age 2. Prior total proctocolectomy with end ileostomy 3. History of inflammatory bowel disease 4. History of diabetes mellitus and are currently on medical diabetes therapy 5. History of chronic kidney disease with an eGFR \&lt; 60 mL/min/1.73m2 6. Cancer diagnosis where the subject is receiving active therapy 7. Use of either a ketogenic diet or intermittent fasting (defined as a fasting period of 16 hours or more per day that is not associated with a medical procedure) during the 4 weeks prior to enrollment Part B Inclusion Criteria: 1. Have a diagnosis of FAP with genetic testing demonstrating a pathogenic or likely pathogenic germline variant in APC, must have a clinical FAP phenotype with at least one member of the family who has a pathogenic or likely pathogenic germline variant in APC, or must have a clinical diagnosis of FAP as agreed by two gastrointestinal cancer genetics experts. 2. Willing to undergo a colonoscopy or sigmoidoscopy, which may be part of the patient's routine standard care. 3. Able to have a concurrent upper endoscopy performed with the colonoscopy/sigmoidoscopy. This upper endoscopy may be part of the patient's routine standard care. 4. Have at least two colorectal polyps at enrollment (which can be present anywhere in the colon including the rectal cuff, or in the J-pouch \[if applicable\]). 5. Can provide informed consent. Exclusion Criteria: 1. Subject is pregnant, a prisoner, or is under 18 years of age 2. Patient is not able to undergo colonoscopy/sigmoidoscopy or upper endoscopy 3. Prior total proctocolectomy with end ileostomy 4. History of inflammatory bowel disease 5. History of diabetes mellitus and are currently on medical diabetes therapy 6. History of chronic kidney disease with an eGFR \< 60 mL/min/1.73m2 7. Cancer diagnosis where the subject is receiving active therapy 8. Use of either a ketogenic diet or intermittent fasting (defined as a fasting period of 16 hours or more per day that is not associated with a medical procedure) during the 4 weeks prior to enrollment 9. Regular use of any FAP-related chemopreventive agent in the 6 weeks prior to enrollment including aspirin (\> 81mg daily), NSAIDs, BHB supplementation, or any other medication deemed a chemopreventive agent by the study investigators 10. Any colonic or small intestinal polyp observed endoscopically that is \> 1 cm in size and is not removed (excluding ampullary adenomas)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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