Faecal Microbiota Transplantation for Patients With Diabetes Mellitus Type 1 and Severe Gastrointestinal Neuropathy: a Randomised, Double-blinded Safety and Pilot-efficacy Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Faecal Microbiota Transplantation (FMT)
- Sponsor
- University of Aarhus
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of adverse events of severity grade 2 or more assessed by CTCAE v5.0 during the first week after first intervention (FMT or placebo).
- Status
- Completed
- Last Updated
- last year
Overview
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 severe gastrointestinal neuropathy in patients with diabetes mellitus type 1.
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 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.
Investigators
Eligibility Criteria
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 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
Outcomes
Primary Outcomes
Number of adverse events of severity grade 2 or more assessed by CTCAE v5.0 during the first week after first intervention (FMT or placebo).
Time Frame: One week after the first intervention
Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.
Secondary Outcomes
- Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.(One week after each intervention)
- Patient-reported outcomes from questionnaires.(at baseline and 4 weeks after each intervention period and at long term follow-up at week 26)
- Objective measures from the breath test.(at baseline and 4 weeks after the first intervention)
- Blood samples.(at baseline and 4 weeks after each intervention period)
- Patient-reported outcomes obtained from the bowel habit diary.(Each patient fills out the diary every day for one week at baseline, for one week starting at each day of the two interventions and for one week at the long term follow-up at week 26)
- Microbiota analysis on faecal samples.(at baseline and 4 weeks after each intervention period)
- Objective measures from the wireless motility capsule.(at baseline and 4 weeks after each intervention period)
- Objective measures from the low-dose CT scan.(at baseline and 4 weeks after the first intervention)