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Butyrate Adjuvant Therapy for Type 1 Diabetes

NCT03999853 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-03-31

Study results available
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Summary

The investigators are interested to evaluate the effect of BKR-017 (colon-targeted 500 mg butyrate tablets) as adjuvant therapy on metabolic control in type 1 diabetes (TID) subjects.

Conditions

  • Type1diabetes

Interventions

DRUG

BKR-017

BKR-017

Sponsors & Collaborators

  • BioKier Inc.

    collaborator INDUSTRY

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Adrian Vella, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-28
Primary Completion
2025-04-01
Completion
2025-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03999853 on ClinicalTrials.gov