Could a gut pill help type 1 diabetes? small trial explores Butyrate's potential
NCT ID NCT03999853
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.
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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
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Dec 2025
- Lead sponsor
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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.
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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.
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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.
Contacts and locations
Locations
-
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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Other studies related to the condition(s) this trial covers.
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