Fecal Microbiota Transplantation Intervention on Microbiota Composition and Insulin Sensitivity in Diabetes (FeMIC)

Central Jutland Regional Hospital

Status: Not yet enrolling

Conditions: Oral Glucose Tolerance Test; Fecal Microbiota Transplantation (FMT); Diabetes Mellitus Type 2; Continuous Glucose Monitoring

Treatments: Other: Placebo; Other: Fecal Microbial Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT07375797

1-10-72-140-23

Details and patient eligibility

About

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.

Full description

People with type 2 diabetes have been shown to exhibit an altered composition of the gut microbiota, including a reduced abundance of butyrate-producing bacteria. Although the underlying mechanisms are not fully elucidated, alterations in gut microbiota composition may be important in the pathogenesis of type 2 diabetes and in metabolic regulation. Fecal microbiota transplantation (FMT) from lean donors has been shown to transiently improve insulin sensitivity and increase the abundance of butyrate-producing bacteria in individuals with metabolic syndrome.

A double-blinded, randomized, placebo-controlled trial will be conducted to investigate the effects of FMT on glycaemic metabolism and gut microbiota composition in individuals with type 2 diabetes. A total of 16 participants will be randomly assigned to one of two groups, receiving either FMT or placebo.

Glycaemic metabolism will be assessed at baseline and again at week 7 post-intervention using three complementary measures: the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), an oral glucose tolerance test (OGTT) for the Matsuda index, and continuous glucose monitoring (CGM). In addition, stool samples will be collected before and after the intervention to evaluate changes in gut microbiota composition following FMT, for example using 16S rRNA gene sequencing.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

Fecal Microbiota Transplantation

Experimental group

Description:

The participants will receive two rounds of FMT with two weeks between each treatment.

Treatment:

Other: Fecal Microbial Transplantation

Placebo

Placebo Comparator group

Description:

Placebo capsules visually identical to FMT capsules

Treatment:

Other: Placebo