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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
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).
The placebo capsules are produced from a suspension of 50% glycerol, 40% sterile saline and 10% food coloring in enterocapusles
Aarhus University Hospital
Aarhus, Denmark
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.
Time frame: One week after the first intervention
Patient-reported outcomes obtained from the bowel habit diary.
Stool consistency measured by the Bristol scale from 1(severe constipation) to 7 (severe diarrhea)
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
Patient-reported outcomes obtained from the bowel habit diary.
Median number of bowel openings per 24 hours.
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
Patient-reported outcomes obtained from the bowel habit diary.
Number of nightly bowel openings (from bedtime until morning).
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
Patient-reported outcomes obtained from the bowel habit diary.
Number of episodes with involuntary defaecation.
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
Patient-reported outcomes obtained from the bowel habit diary.
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Glycemic control measured by patient reported use of insulin (IE).
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
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.
Time frame: One week after each intervention
Patient-reported outcomes from questionnaires.
Change in Gastrointestinal syndrome rating scale - irritable bowel version questionnaire (GSRS-IBS)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: at baseline and 4 weeks after each intervention period
Objective measures from the wireless motility capsule.
Colonic transit time.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at baseline and 4 weeks after the first intervention
Microbiota analysis on faecal samples.
Alpha-diversity of faecal microbiota, 16S. Dysbiosis index.
Time frame: at baseline and 4 weeks after each intervention period
Microbiota analysis on faecal samples.
Dysbiosis index.
Time frame: at baseline and 4 weeks after each intervention period
Blood samples.
Glycemic control measured by HbA1C levels.
Time frame: at baseline and 4 weeks after each intervention period