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

NCT07375797 | Active Not Recruiting

• 1 other identifier: 1-10-72-140-23
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Fecal Microbiota Transplantation; FMT; Insulin Sensitivity; Type II Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Time-in-range

  At baseline and at week 7

• Hemoglobin A1c

  At baseline and at week 7

• Glucose management indicator

  At baseline and at week 7

• Body mass index

  At baseline and at week 7

• Waist circumference

  At baseline and at week 7

Other Outcomes (6)

• LEAP-2/ghrelin

  At baseline and at week 7

• GLP-1

  At baseline and at week 7

• Interleukin 1-beta

  At baseline and at week 7

Study Arms (2)

Fecal Microbiota Transplantation

EXPERIMENTAL

The participants will receive two rounds of FMT with two weeks between each treatment.

Other: Fecal Microbial Transplantation

Placebo

PLACEBO COMPARATOR

Placebo capsules visually identical to FMT capsules

Other: Placebo

Interventions

Placebo OTHER

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.

Also known as: Placebo capsules

Placebo

Fecal Microbial Transplantation OTHER

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.

Also known as: FMT

Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has type 2 diabetes

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead
• Aarhus University Hospital: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Medical Diagnostics Center, Regional Hospital Central Jutland (HEM)

Viborg, 8800, Denmark

Location

Related Links

• Centre for Faecal Microbiota Transplantation - CEFTA

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Endocrinologist

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 29, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

DK (1)