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

Not Applicable

Completed

• Conditions: Gastrointestinal Neuropathy; Faecal Microbiota Transplantation (FMT); Diabetes Mellitus, Type 1
• Interventions: Other: Faecal microbiota transplantation (FMT) capsules; Other: Placebo capsules

• Registration Number: NCT04749030
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-10
• Study Start: 2021-06-15
• Status Verified: 2022-05
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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
• Patients with pacemaker/ICD
• Previous abdominal surgery
• Changes in medicine that affects the GI tract in the prior 4 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Faecal microbiota transplantation (FMT)	Faecal microbiota transplantation (FMT) capsules	Donor faeces is obtained from thoroughly screened healthy blood donors and processed in compliance with the European Tissue and Cells Directive.
Placebo	Placebo capsules	Placebo capsules will be identical in terms of visual appearance, weight, and vials and number

Primary Outcome Measures

Name	Time	Method
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).	One week after the first intervention	Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.

Secondary Outcome Measures

Name	Time	Method
Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.	One week after each intervention	Mild adverse events (grade 1) following FMT or placebo assessed by CTCAE v5.0.
Patient-reported outcomes from questionnaires.	at baseline and 4 weeks after each intervention period and at long term follow-up at week 26	Change in irritable bowel syndrome impact scale (IBS-IS)
Objective measures from the breath test.	at baseline and 4 weeks after the first intervention	Rise in hydrogen PPM measured in breath test for small intestinal bacterial overgrowth.
Blood samples.	at baseline and 4 weeks after each intervention period	Glycemic control measured by HbA1C levels.
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	Glycemic control measured by patient reported use of insulin (IE).
Microbiota analysis on faecal samples.	at baseline and 4 weeks after each intervention period	Dysbiosis index.
Objective measures from the wireless motility capsule.	at baseline and 4 weeks after each intervention period	pH drop from the small intestine to the colon.
Objective measures from the low-dose CT scan.	at baseline and 4 weeks after the first intervention	Volume of the a) small intestine and b) the colon. Volume of gas in a) the small intestine and b) the colon.

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark