Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a gut pill help type 1 diabetes? small trial explores Butyrate's potential

NCT ID NCT03999853

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested whether a colon-targeted butyrate tablet (BKR-017) could help people with type 1 diabetes improve insulin sensitivity and lower triglycerides. Six adults with type 1 diabetes took the tablets for 28 days alongside their usual care. The goal was to see if this supplement could be a helpful add-on therapy, not a replacement for insulin.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

6 people

The number who actually took part.

Started

Jul 2022

Finished

Dec 2025

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

20 to 80 years

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.

Inclusion Criteria: 1. Diagnosed with T1D and under the care of a healthcare professional for its management 2. HbA1c 6.4-8.9%, inclusive 3. Has given written informed consent to participate in this study 4. Willing to complete 28-day baseline period and 48 -day test period 5. Willing to maintain current diet and exercise routine for the duration of the study 6. Current use of a Dexcom Continuous Glucose Monitor (CGM) Exclusion Criteria: 1. History of bariatric or intestinal surgery 2. Active gastrointestinal disease including but not limited to irritable bowel syndrome, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), diverticulitis, gastroparesis, or chronic/frequent diarrhea or chronic/frequent constipation 3. Active and clinically significant hepatic, pancreatic disease, or renal disease as determined by the investigator 4. History of significant heart disease, including congestive heart failure, prior MI, chronic atrial or ventricular fibrillation, coronary artery disease, cerebral vascular disease, or other cardiovascular disease, that in the opinion of the investigator should exclude the subject from the study 5. Severely uncontrolled hypertension at screening defined as a systolic blood pressure \> 180 mmHg or a diastolic blood pressure \> 110 mmHg on the average of two seated measurements after being at rest for at least 5 minutes 6. Uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease 7. Active significant infection as determined by the investigator 8. Known allergy to butyrate or any of the components of the tablets 9. Participation in a clinical trial and/or treatment with an investigational drug during the 30 days before screening, or within 5 half-lives of receipt of an investigational drug or twice the duration of the biological effect of any investigational drug (whichever is longer) 10. Pregnant, nursing, or trying to become pregnant 11. Presence of pitting edema on physical exam 12. High fiber diet 13. In the investigator's judgment, the subject is not suitable for the study for any other reason or cannot commit to the requirements of the study. 14. Subject is taking one or more of the excluded therapies.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for TYPE1DIABETES are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Contacts and locations

Locations

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.