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Fecal Microbiota Transplantation Intervention on Microbiota Composition and Insulin Sensitivity in Diabetes
Sponsor: Central Jutland Regional Hospital
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.
Key Details
Gender
All
Age Range
18 Years - 67 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2026-02-05
Completion Date
2026-09
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Medical Diagnostics Center, Regional Hospital Central Jutland (HEM)
Viborg, Denmark