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

NCT ID: NCT04749030

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2023-10-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Faecal microbiota transplantation (FMT)

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

Group Type OTHER

Faecal microbiota transplantation (FMT) capsules

Intervention Type 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).

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo capsules

Intervention Type OTHER

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

Interventions

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Faecal microbiota transplantation (FMT) capsules

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).

Intervention Type OTHER

Placebo capsules

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Klaus Krogh, MD, DMSc, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Hepatology and Gastroenterology, Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 28863010 (View on PubMed)

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 Sep 18. doi: 10.1007/s00125-025-06544-x. Online ahead of print.

Reference Type DERIVED
PMID: 40965701 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39791110 (View on PubMed)

Other Identifiers

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Fadigas

Identifier Type: -

Identifier Source: org_study_id