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RECRUITING
NCT07375797
NA

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

Sponsor: Central Jutland Regional Hospital

View on ClinicalTrials.gov

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

Interventions

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