Clinical trial NCT04749030: Faecal Microbiota Transplantation for Patients With Diabetes Mellitus Type 1 and Severe Gastrointestinal Neuropathy
Official title: Faecal Microbiota Transplantation for Patients With Diabetes Mellitus Type 1 and Severe Gastrointestinal Neuropathy: a Randomised, Double-blinded Safety and Pilot-efficacy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Faecal Microbiota Transplantation (FMT)
Diabetes Mellitus, Type 1
Gastrointestinal Neuropathy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: One week after the first intervention
Secondary outcomes:
measure: Patient-reported outcomes obtained from the bowel habit diary.
timeFrame: 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
measure: Patient-reported outcomes obtained from the bowel habit diary.
timeFrame: 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
measure: Patient-reported outcomes obtained from the bowel habit diary.
timeFrame: 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
measure: Patient-reported outcomes obtained from the bowel habit diary.
timeFrame: 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
measure: Patient-reported outcomes obtained from the bowel habit diary.
timeFrame: 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
measure: Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.
timeFrame: One week after each intervention
measure: Patient-reported outcomes from questionnaires.
timeFrame: at baseline and 4 weeks after each intervention period and at long term follow-up at week 26
measure: Patient-reported outcomes from questionnaires.
timeFrame: at baseline and 4 weeks after each intervention period and at long term follow-up at week 26
measure: Patient-reported outcomes from questionnaires.
timeFrame: at baseline and 4 weeks after each intervention period and at long term follow-up at week 26
measure: Objective measures from the wireless motility capsule.
timeFrame: at baseline and 4 weeks after each intervention period
measure: Objective measures from the wireless motility capsule.
timeFrame: at baseline and 4 weeks after each intervention period
measure: Objective measures from the wireless motility capsule.
timeFrame: at baseline and 4 weeks after each intervention period
measure: Objective measures from the low-dose CT scan.
timeFrame: at baseline and 4 weeks after the first intervention
measure: Objective measures from the breath test.
timeFrame: at baseline and 4 weeks after the first intervention
measure: Microbiota analysis on faecal samples.
timeFrame: at baseline and 4 weeks after each intervention period
measure: Microbiota analysis on faecal samples.
timeFrame: at baseline and 4 weeks after each intervention period
measure: Blood samples.
timeFrame: at baseline and 4 weeks after each intervention period
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Department of Hepatology and Gastroenterology, Aarhus University Hospital
name: Klaus Krogh, MD, DMSc, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.