BetaFIT

UnknownPhase 2

BetaFIT Study: Beta Cell Imaging After Faecal mIcrobiota Transplantation

The Effects of Faecal Microbiota Transplantation on Beta Cell Preservation in Patients With Newly Diagnosed Type 1 Diabetes

Lead sponsor

Radboud University Medical Center

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Type 1 diabetes

Key I/E criterion

•BMI 18-30

Primary endpoint

•Correlation between residual beta cell mass and function

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05622123

Org study IDNL81554.091.22

Timeline

Milestones

Study first posted2022-11-18actual

Study start2023-02-23actual

Last update posted2023-04-04actual

Primary completion2024-02-28estimated

Study completion2024-03-30estimated

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Previously participated in ENCAPSULATE-DM1 or FMT preserve-DM1 trial

•Type 1 diabetes with the diagnosis being made in the last 4.5 years

•Presence of at least one autoantibody associated with type 1 diabetes (anti-GAD-65, anti-IA2, islet cell antibodies, insulin autoantibodies)

•Age ≥ 18 years

•BMI 18-30 kg/m2

•Insulin use

Exclusion criteria

•Inability to provide written informed consent

•Other medication use than insulin

•Smoking

•Evidence of compromised immunity

•Presence of a second autoimmune disease (other than type 1 diabetes); e.g. celiac disease, hyper- or hypothyroidism, inflammatory bowel disease. Vitiligo is allowed.

•Pregnancy or the wish to become pregnant within 1 month after the study

•Breastfeeding

•Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range

•Renal disease defined as MDRD < 40 ml/min/1.73 m²

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Correlation between residual beta cell mass and function

Time frame:1 year

descriptive

Secondary/protocol endpoint/low confidence

Correlation with other parameters

Time frame:1 year

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.