RecruitingNot ApplicableNCT07375797

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


Sponsor

Central Jutland Regional Hospital

Enrollment

16 participants

Start Date

Feb 5, 2026

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 YearsMax Age: 67 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether fecal microbiota transplantation (FMT) — transferring healthy gut bacteria from a donor into a patient's digestive system — can improve gut bacteria balance and help the body respond better to insulin in people with type 2 diabetes. **You may be eligible if...** - You have been diagnosed with type 2 diabetes **You may NOT be eligible if...** - You currently use insulin or sulfonylurea diabetes medications - You have taken antibiotics, probiotics, or acid-reducing medications in the past 3 months - You exercise more than 150 minutes per week at moderate intensity - You have heart disease, lung disease, liver or gallbladder disease, or serious kidney problems - You have inflammatory bowel disease, chronic diarrhea, or other gut conditions - You are pregnant or planning to become pregnant - You have a history of drug or alcohol abuse - You have anemia or bone marrow disorders - You have food allergies or reactions to medical equipment used in the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERFecal 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.

OTHERPlacebo

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

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NCT07375797