Faecal Microbiota Transplantation for Patients With Diabetes Mellitus Type 1 and Severe Gastrointestinal Neuropathy (Fadigas)

  • End date
    Jan 1, 2025
  • participants needed
  • sponsor
    University of Aarhus
Updated on 16 June 2022


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.


Diabetes type 1 may cause damage to nerve cells in the gut causing neuropathy that leads to changes in gastric and intestinal motility. This change predisposes to an abnormal amounts and composition of bacteria in the gut, probably leading to uncontrollable diarrhea and severely impaired quality of life. Transferal of intestinal microbiota from a healthy donor to a patient is called faecal microbiota transplantation (FMT). FMT may potentially change the bacteria in the gut and reduce gastrointestinal symptoms. However, FMT may also have potential side effects, especially in persons with autonomic neuropathy and delayed transit through the gut.

Condition Faecal Microbiota Transplantation (FMT), Diabetes Mellitus, Type 1, Gastrointestinal Neuropathy
Treatment Placebo capsules, Faecal microbiota transplantation (FMT) capsules
Clinical Study IdentifierNCT04749030
SponsorUniversity of Aarhus
Last Modified on16 June 2022


Yes No Not Sure

Inclusion Criteria

Adult (≥ 18 years old), male or female patients with DM1 for at least 5 years and average
of or above 40 points in the questionnaire: Gastrointestinal syndrome rating scale -
irritable bowel syndrome version (GSRS-IBS)

Exclusion Criteria

Inability to understand Danish or the trial procedures
Known or anticipated pregnancy
Known severe renal insufficiency
Antibiotic use in the prior 4 weeks
Treatment with morphine
Ongoing infection with Clostridioides difficile or pathogenic intestinal bacteria or
Known gastrointestinal disease or GI infection
Patients diagnosed with intestinal stricture
Patients with other known disorder that can cause gastroparesis
Patients with planned MR scan within 4 weeks
Patients with pacemaker/ICD
Previous abdominal surgery
Changes in medicine that affects the GI tract in the prior 4 weeks
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