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

Diabetes Mellitus, Type 1 Clinical Trial

— Fadigas  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04749030
• Other study ID #: Fadigas
• Status: Completed
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: May 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Faecal Microbiota Transplantation (FMT)
• Gastrointestinal Neuropathy

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Objective measures from the wireless motility capsule.	Transit time through the small intestine.	at baseline and 4 weeks after each intervention period
Secondary	Objective measures from the wireless motility capsule.	Colonic transit time.	at baseline and 4 weeks after each intervention period
Secondary	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
Secondary	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
Secondary	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
Secondary	Microbiota analysis on faecal samples.	Alpha-diversity of faecal microbiota, 16S. Dysbiosis index.	at baseline and 4 weeks after each intervention period
Secondary	Microbiota analysis on faecal samples.	Dysbiosis index.	at baseline and 4 weeks after each intervention period
Secondary	Blood samples.	Glycemic control measured by HbA1C levels.	at baseline and 4 weeks after each intervention period