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

University of Aarhus

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Faecal Microbiota Transplantation (FMT); Gastrointestinal Neuropathy

Treatments: Other: Placebo capsules; Other: Faecal microbiota transplantation (FMT) capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT04749030

Fadigas

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

20 participants in 2 patient groups, including a placebo group

Faecal microbiota transplantation (FMT)

Other group

Description:

Donor faeces is obtained from thoroughly screened healthy blood donors and processed in compliance with the European Tissue and Cells Directive.

Treatment:

Other: Faecal microbiota transplantation (FMT) capsules

Placebo

Placebo Comparator group

Description:

Placebo capsules will be identical in terms of visual appearance, weight, and vials and number

Treatment:

Other: Placebo capsules