Fecal Microbial Transplantation: The capsules consists of approximately 50 grams of donor feces. This is cryopreserved, homogenized and dispensed into double-coated, acid resistant enterocapsules. A single treatment includes approximately 25 capsules.
The fecal material is obtained from healthy donors, recruited from thoroughly screened healthy blood donors and processed in compliance with the European Tissue and Cells Directive. Further, the donors lipid status and HbA1c is screened, ensuring only metabolically healthy donors are included.
Placebo: The placebo products consists of the same capsules as FMT. The content of the capsules is produced from a suspension of glycerol, saline and food coloring. The number of placebo capsules will correspond to the amount of FMT capsules.
The placebo capsules will be identical in visual appearance.
Study summary
The purpose of the trial is to investigate the effect of fecal microbiota transplantation versus placebo on glycemic metabolism and gut microbiota composition in people with type 2 diabetes.
Eligibility
Sex
ALL
Min age
18 Years
Max age
67 Years
Healthy volunteers
No
Inclusion Criteria:
* Has type 2 diabetes
Exclusion Criteria:
* Treatment with insulin or sulfonylurea drugs.
* Treatment with antibiotics, probiotics/lactic acids cultures, or proton pump inhibitors within the last three months.
* Regular exercise and/or more than 150 minutes of moderate intensity exercise or 75 minutes of high intensity exercise per week, within the last 6 months.
* Diagnosed with unstable angina, recent (within the last 8 weeks) myocardial infarction, any disease in the coronal arteries, decompensated heart failure (NYHA II-IV), severe valvular disease, lung disease
* Hypertension which is not currently under medical control (systolic pressure \>200 mmHg and/or diastolic pressure \>130 mmHg)
* Bariatric surgery within the previous year or a plan to undergo bariatric surgery during the study period
* Self-reported drug or alcohol abuse
* Patients preparing for or currently experiencing pregnancy during the study period
* Disease of the liver and/or gallbladder, including parenchymal liver disease, liver cirrhosis, pancreatitis, autoimmune liver disease
* All diseases of the gastrointestinal tract, which can lead to or increase the risk of defects in the mucosal membrane. This includes chronic diarrhea, inflammatory bowel disease, malabsorption, malnutrition, recent infection with clostridium difficile, primary sclerosing cholangitis, radiation induced enteritis, chemotherapy induced diarrhea, hematological diseases
* Reactive hypoglycemia
* Anemia and other diseases of the bone marrow
* Kidney diseases, including moderate albuminuria and other disturbances in the electrolytes balance
* Food allergies, allergies towards catheters (i.e. Venflon) and other instruments used in the study.
* Other condition deeming individuals inappropriate for recruitment according to the investigators or sponsor
Primary outcome measure(s)
Insulin sensitivity — At baseline and at week 7 Insulin sensitivity assessed by the Matsuda index, calculated from plasma glucose (in mmol/L) and serum insulin(in pmol/L) concentrations measured repeatedly during a standardized oral glucose tolerance test at baseline and after 7 weeks.
Trial sites (1)
Facility
City
Region
Status
Medical Diagnostics Center, Regional Hospital Central Jutland (HEM)
Viborg
Denmark
More Central Jutland Regional Hospital trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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