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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus Type 2; Oral Glucose Tolerance Test; Continuous Glucose Monitoring; Fecal Microbiota Transplantation (FMT)
• Intervention / Treatment: Other: Fecal Microbial Transplantation; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Viborg, Denmark, 8800
    • Medical Diagnostics Center, Regional Hospital Central Jutland (HEM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fecal Microbiota Transplantation; The participants will receive two rounds of FMT with two weeks between each treatment.	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 Names: FMT
Placebo Comparator: Placebo; Placebo capsules visually identical to FMT capsules	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.; Other Names: Placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin sensitivity	Insulin sensitivity assessed by the Matsuda index, calculated from plasma glucose (in mmol/L) and serum insulin(in pmol/L) concentrations measured repeatedly during a standardized oral glucose tolerance test at baseline and after 7 weeks.	At baseline and at week 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-in-range	Percentage of time with interstitial glucose values between 3.9 and 10.0 mmol/L, derived from continuous glucose monitoring data collected over a 10-day period at baseline and during the final two weeks of the intervention.	At baseline and at week 7
Hemoglobin A1c	Hemoglobin A1c in plasma (in mmol/mol)	At baseline and at week 7
Glucose management indicator	Glucose management indicator (GMI) calculated from mean interstitial glucose values derived from continuous glucose monitoring data collected over a 10-day period at baseline and during the final two weeks of the intervention.	At baseline and at week 7
Body mass index	Weight (in kilograms), height (in meters) for calculation of BMI	At baseline and at week 7
Waist circumference	Waist circumference(in centimeters)	At baseline and at week 7
Microbiome analysis	Fecal samples will be collected and analyzed to characterize the gut microbiome and its changes in response to the intervention. Analyses may include 16S rRNA gene sequencing and/or other molecular or biochemical methods to assess microbial composition, diversity, and selected functional features. The specific analytical methods will be defined prior to analysis.	At baseline and at week 7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
LEAP-2/ghrelin	LEAP-2/ghrelin (arbitrary units, with LEAP-2 and ghrelin in ng/ml)	At baseline and at week 7
GLP-1	glukagonlike peptide-1 (in pmol/l)	At baseline and at week 7
Interleukin 1-beta	IL1B measured with Multiplex (in pg/ml)	At baseline and at week 7
Triglycerides	Measurements of serum triglycerides (in mmol/L)	At baseline and at week 7
C-reactive protein	C-reactive protein (mg/L))	At baseline and at week 7
Remnant cholesterol	Remnant is calculated from Total, LDL, and HDL-cholesterol (all in mmol/L)	At baseline and at week 7

Collaborators and Investigators

• Sponsor: Central Jutland Regional Hospital
• Collaborators: Aarhus University Hospital; University of Aarhus

Publications and helpful links

Helpful Links

• Centre for Faecal Microbiota Transplantation - CEFTA

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2026
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Type II Diabetes; Fecal Microbiota Transplantation; FMT; Insulin Sensitivity
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperinsulinism; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Insulin Resistance
• Other Study ID Numbers: 1-10-72-140-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared upon reasonable request to the corresponding author. Data will be de-identified where possible and made available to qualified researchers for scientific purposes. Due to the small sample size and risk of re-identification, data will not be deposited in a public repository
• IPD Sharing Time Frame: Data will be available beginning after publication of the primary study results and will remain available for a reasonable period thereafter, subject to continued data governance and ethical approval.
• IPD Sharing Access Criteria: Access to IPD and supporting information will be granted to qualified researchers with a scientifically sound research proposal. Requests will be reviewed by the study investigators. Approved users will receive access to de-identified data relevant to the approved analysis, following execution of a data use agreement. Data will be shared via secure data transfer. Due to the small sample size, full datasets will not be made publicly available.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No