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

NCT04749030 | Completed DMC

• 1 other identifier: Fadigas
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.

  One week after the first intervention

Secondary Outcomes (17)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Faecal microbiota transplantation (FMT)

OTHER

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

Other: Faecal microbiota transplantation (FMT) capsules

Placebo

PLACEBO COMPARATOR

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

Other: Placebo capsules

Interventions

Faecal microbiota transplantation (FMT) capsules OTHER

The faeces is minimally processed through a series of centrifugation steps and dispensed into double-coated, acid resistant enterocapsules. A single treatment includes approximately 22 capsules (\~50 grams of original donor faeces).

Faecal microbiota transplantation (FMT)

Placebo capsules OTHER

The placebo capsules are produced from a suspension of 50% glycerol, 40% sterile saline and 10% food coloring in enterocapusles

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (3)

• Jorgensen SMD, Hansen MM, Erikstrup C, Dahlerup JF, Hvas CL. Faecal microbiota transplantation: establishment of a clinical application framework. Eur J Gastroenterol Hepatol. 2017 Nov;29(11):e36-e45. doi: 10.1097/MEG.0000000000000958.

  PMID: 28863010 BACKGROUND

• Hoyer KL, Kornum DS, Baunwall SMD, Klinge MW, Drewes AM, Yderstraede KB, Mikkelsen S, Erikstrup C, Krogh K, Hvas CL. Repeated faecal microbiota transplantation for individuals with type 1 diabetes and gastroenteropathy. Diabetologia. 2025 Dec;68(12):2795-2806. doi: 10.1007/s00125-025-06544-x. Epub 2025 Sep 18.

  PMID: 40965701 DERIVED

• Hoyer KL, Dahl Baunwall SM, Kornum DS, Klinge MW, Drewes AM, Yderstraede KB, Thingholm LB, Mortensen MS, Mikkelsen S, Erikstrup C, Hvas CL, Krogh K. Faecal microbiota transplantation for patients with diabetes type 1 and severe gastrointestinal neuropathy (FADIGAS): a randomised, double-blinded, placebo-controlled trial. EClinicalMedicine. 2024 Dec 16;79:103000. doi: 10.1016/j.eclinm.2024.103000. eCollection 2025 Jan.

  PMID: 39791110 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Fecal Microbiota Transplantation; Capsules

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Klaus Krogh, MD, DMSc, PhD, Professor

  Department of Hepatology and Gastroenterology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a 8-week, randomised, double-blinded, placebo-controlled pilot trial of oral FMT versus placebo in patients with DM1 and severe GI neuropathy. The intervention period consists of a first 4 weeks where patients receive either FMT or placebo and a second 4 weeks where all patients receive FMT. The patients will undergo the investigations before and after each 4-week period.

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 10, 2021
• Study Start: June 15, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 13, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)