NCT07375797

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Central Jutland Regional Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 67 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-05
• Primary completion: 2026-06-25
• Completion: 2026-09-01
• First posted: 2026-01-29
• Last updated: 2026-04-08

Locations

1 site across 1 country: Denmark