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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | Placebo capsules will be identical in terms of visual appearance, weight, and vials and number |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported outcomes obtained from the bowel habit diary. | Stool consistency measured by the Bristol scale from 1(severe constipation) to 7 (severe diarrhea) | 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Krogh, MD, DMSc, PhD, Professor | Department of Hepatology and Gastroenterology, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28863010 | Background | 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. | |
| 40965701 | Derived | 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. |
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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.
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|
| Placebo capsules | Other | The placebo capsules are produced from a suspension of 50% glycerol, 40% sterile saline and 10% food coloring in enterocapusles |
|
| Patient-reported outcomes obtained from the bowel habit diary. | Median number of bowel openings per 24 hours. | 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. | Number of nightly bowel openings (from bedtime until morning). | 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. | Number of episodes with involuntary defaecation. | 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. | Glycemic control measured by patient reported use of insulin (IE). | 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 measures from the schedule of side effects and telephone call 1 week after each intervention. | Mild adverse events (grade 1) following FMT or placebo assessed by CTCAE v5.0. | One week after each intervention |
| Patient-reported outcomes from questionnaires. | Change in Gastrointestinal syndrome rating scale - irritable bowel version questionnaire (GSRS-IBS) | at baseline and 4 weeks after each intervention period and at long term follow-up at week 26 |
| Patient-reported outcomes from questionnaires. | Change in patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) | at baseline and 4 weeks after each intervention period and at long term follow-up at week 26 |
| Patient-reported outcomes from questionnaires. | Change in irritable bowel syndrome impact scale (IBS-IS) | at baseline and 4 weeks after each intervention period and at long term follow-up at week 26 |
| Objective measures from the wireless motility capsule. | Transit time through the small intestine. | at baseline and 4 weeks after each intervention period |
| Objective measures from the wireless motility capsule. | Colonic transit time. | at baseline and 4 weeks after each intervention period |
| Objective measures from the wireless motility capsule. | pH drop from the small intestine to the colon. | at baseline and 4 weeks after each intervention period |
| Objective measures from the low-dose CT scan. | Volume of the a) small intestine and b) the colon. Volume of gas in a) the small intestine and b) the colon. | at baseline and 4 weeks after the first intervention |
| Objective measures from the breath test. | Rise in hydrogen PPM measured in breath test for small intestinal bacterial overgrowth. | at baseline and 4 weeks after the first intervention |
| Microbiota analysis on faecal samples. | Alpha-diversity of faecal microbiota, 16S. Dysbiosis index. | at baseline and 4 weeks after each intervention period |
| Microbiota analysis on faecal samples. | Dysbiosis index. | at baseline and 4 weeks after each intervention period |
| Blood samples. | Glycemic control measured by HbA1C levels. | at baseline and 4 weeks after each intervention period |
| 39791110 | 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. |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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