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RECRUITINGINTERVENTIONAL

Fecal Microbiota Transplantation Intervention on Microbiota Composition and Insulin Sensitivity in Diabetes

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Has type 2 diabetes Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

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.

OTHER

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.

Locations (1)

Medical Diagnostics Center, Regional Hospital Central Jutland (HEM)
Viborg, Denmark