CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Faecal microbiota transplantation (FMT) capsules +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04749030
NCT04749030N/ACompleted
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Faecal Microbiota Transplantation for Patients With Diabetes Mellitus Type 1 and Severe Gastrointestinal Neuropathy: a Randomised, Double-blinded Safety and Pilot-efficacy Study

University of Aarhus·interventional·Posted Feb 10, 2021·Updated Dec 13, 2024

In Brief

A clinical study evaluating Faecal microbiota transplantation (FMT) capsules and Placebo capsules for Faecal Microbiota Transplantation (FMT) and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

A randomised, double-blinded and placebo-controlled intervention study. The study aim to evaluate the feasibility, safety and pilot-efficacy of faecal microbiota transplantation as a treatment of severe gastrointestinal neuropathy in patients with diabetes mellitus type 1.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFaecal Microbiota Transplantation (FMT), Diabetes Mellitus, Type 1, Gastrointestinal Neuropathy
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 10, 2021
Enrollment StartJun 15, 2021
Primary CompletionOct 1, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.4 years ago

Interventions

Faecal microbiota transplantation (FMT) capsulesother

The faeces is minimally processed through a series of centrifugation steps and dispensed into double-coated, acid resistant enterocapsules. A single treatment includes approximately 22 capsules (\~50 grams of original donor faeces).

Placebo capsulesother

The placebo capsules are produced from a suspension of 50% glycerol, 40% sterile saline and 10% food coloring in enterocapusles