BetaFIT Study: Beta Cell Imaging After Faecal mIcrobiota Transplantation

What Was Tested

This registered phase 2 trial tested Exenatide.

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.

It had 1 arm (groups): Patients with type 1 diabetes who have completed the ENCAPSULATE-DM1 or FMT preserve-DM1 trial (experimental).

PET/CT imaging after injection with 68Ga-NODAGA-exendin-4 to quantify beta cell mass.

The registry classes the interventions as drug.

More on the Plan

Indeed, an altered composition of the faecal microbiota composition was observed in adolescent T1D patients.

A previous study by de Groot et al.

In this study, the investigators aim to investigate whether beta cell mass (quantified by 68Ga-NODAGA-exendin-4 PET/CT imaging) is correlated to beta cell function after autologous faecal microbial transplantation in patients with newly diagnosed type 1 diabetes.

Who Took Part

The registry lists 20 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Previously participated in ENCAPSULATE-DM1 or FMT preserve-DM1 trial. Type 1 diabetes with the diagnosis being made in the last 4.5 years. Age ≥ 18 years. BMI 18-30 kg/m2.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: inability to provide written informed consent; other medication use than insulin; evidence of compromised immunity.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-02-23 with completion listed for 2024-02-28.

It ran at 1 site in Netherlands.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Correlation between residual beta cell mass and function (time frame: 1 year).

It also tracked 1 secondary outcome, for example Correlation with other parameters.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Exenatide in 20 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.