Status:
COMPLETED
Faecal Microbiota Transplantation for Patients With Diabetes Mellitus Type 1 and Severe Gastrointestinal Neuropathy
Lead Sponsor:
University of Aarhus
Conditions:
Faecal Microbiota Transplantation (FMT)
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief 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 seve...
Detailed 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 o...
Eligibility Criteria
Inclusion
- 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
- 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 parasites
- 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
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04749030
Start Date
June 15 2021
End Date
October 1 2023
Last Update
December 13 2024
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200