Faecal Microbiota Transplantation for Patients With Diabetes Mellitus Type 1 and Severe Gastrointestinal Neuropathy (Fadigas)
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- STATUS
- Recruiting
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- End date
- Jan 1, 2025
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- participants needed
- 20
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- sponsor
- University of Aarhus
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.
Description
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.
Details
| Condition | Faecal Microbiota Transplantation (FMT), Diabetes Mellitus, Type 1, Gastrointestinal Neuropathy |
|---|---|
| Treatment | Placebo capsules, Faecal microbiota transplantation (FMT) capsules |
| Clinical Study Identifier | NCT04749030 |
| Sponsor | University of Aarhus |
| Last Modified on | 16 June 2022 |
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