BetaFIT Study: Beta Cell Imaging After Faecal mIcrobiota Transplantation

• Status: Recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

The main goal is to investigate whether beta cell mass is correlated to beta cell function after autologous faecal microbial transplantation (FMT) in patients with newly diagnosed type 1 diabetes

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University Medical Center
• Treatments: Exenatide

Criteria

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