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Completed

NCT Number: NCT04749030

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

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.

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Key information

Conditions

Faecal Microbiota Transplantation (FMT) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Gastrointestinal Neuropathy Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Placebo Capsules

Other

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

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).

    Time frame: One week after the first intervention

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

Secondary outcomes

  1. Patient-reported outcomes obtained from the bowel habit diary.

    Time frame: 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

    Stool consistency measured by the Bristol scale from 1(severe constipation) to 7 (severe diarrhea)

  2. Patient-reported outcomes obtained from the bowel habit diary.

    Time frame: 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

    Median number of bowel openings per 24 hours.

  3. Patient-reported outcomes obtained from the bowel habit diary.

    Time frame: 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

    Number of nightly bowel openings (from bedtime until morning).

  4. Patient-reported outcomes obtained from the bowel habit diary.

    Time frame: 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

    Number of episodes with involuntary defaecation.

  5. Patient-reported outcomes obtained from the bowel habit diary.

    Time frame: 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).

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

    Time frame: One week after each intervention

    Mild adverse events (grade 1) following FMT or placebo assessed by CTCAE v5.0.

  7. Patient-reported outcomes from questionnaires.

    Time frame: at baseline and 4 weeks after each intervention period and at long term follow-up at week 26

    Change in Gastrointestinal syndrome rating scale - irritable bowel version questionnaire (GSRS-IBS)

  8. Patient-reported outcomes from questionnaires.

    Time frame: at baseline and 4 weeks after each intervention period and at long term follow-up at week 26

    Change in patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM)

  9. Patient-reported outcomes from questionnaires.

    Time frame: 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)

  10. Objective measures from the wireless motility capsule.

    Time frame: at baseline and 4 weeks after each intervention period

    Transit time through the small intestine.

  11. Objective measures from the wireless motility capsule.

    Time frame: at baseline and 4 weeks after each intervention period

    Colonic transit time.

  12. Objective measures from the wireless motility capsule.

    Time frame: at baseline and 4 weeks after each intervention period

    pH drop from the small intestine to the colon.

  13. Objective measures from the low-dose CT scan.

    Time frame: 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.

  14. Objective measures from the breath test.

    Time frame: at baseline and 4 weeks after the first intervention

    Rise in hydrogen PPM measured in breath test for small intestinal bacterial overgrowth.

  15. Microbiota analysis on faecal samples.

    Time frame: at baseline and 4 weeks after each intervention period

    Alpha-diversity of faecal microbiota, 16S. Dysbiosis index.

  16. Microbiota analysis on faecal samples.

    Time frame: at baseline and 4 weeks after each intervention period

    Dysbiosis index.

  17. Blood samples.

    Time frame: at baseline and 4 weeks after each intervention period

    Glycemic control measured by HbA1C levels.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Faecal Microbiota Transplantation for Patients With Diabetes Mellitus Type 1 and Severe Gastrointestinal Neuropathy: a Randomised, Double-blinded Safety and Pilot-efficacy Study

Acronym: Fadigas

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2021
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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