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

NCT04749030 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-12-13

No results posted yet for this study

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

Interventions

OTHER

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).

OTHER

Placebo capsules

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

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Klaus Krogh, MD, DMSc, PhD, Professor · Department of Hepatology and Gastroenterology, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2023-10-01
Completion
2023-10-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04749030 on ClinicalTrials.gov