Effects of Fecal Microbiota Transplantation in Patients With Type 2 Diabetes and Coronary Artery Disease (CAD-Microbiome) - A Pilot Study

NCT07421947 | Not Yet Recruiting

• 1 other identifier: BASEC 2025-01754
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study investigates whether fecal microbiota transplantation (FMT) can modify the gut microbiome in patients with type 2 diabetes mellitus and stable coronary artery disease (CAD). Type 2 diabetes and CAD are closely linked metabolic and inflammatory conditions associated with substantial morbidity and mortality. Emerging evidence suggests that the gut microbiome plays an important role in metabolic regulation, systemic inflammation, and cardiovascular disease. Alterations in gut microbial composition have been associated with insulin resistance, dyslipidemia, and atherosclerosis. Modulation of the gut microbiome therefore represents a promising investigational therapeutic strategy. FMT is an established medical procedure involving the transfer of processed stool from a carefully screened healthy donor into the gastrointestinal tract of a recipient with the aim of altering the gut microbial ecosystem. FMT has demonstrated clinical efficacy in specific indications and is generally considered safe when performed under standardized conditions with rigorous donor screening. In this prospective, single-arm, single-center pilot study, eligible patients with type 2 diabetes and stable CAD will undergo FMT administered via colonoscopy. The primary objective is to evaluate whether FMT induces measurable changes in gut microbiome composition six months following the intervention. Secondary objectives include assessment of temporal microbiome dynamics at earlier time points, as well as evaluation of potential effects on the oral microbiome, metabolic parameters, lipid profile, glucose homeostasis, inflammatory biomarkers, and vascular function. Participants will be monitored throughout the study period for safety and tolerability. The study is designed to evaluate feasibility, characterize microbiome alterations, and explore potential biological effects rather than to demonstrate definitive clinical efficacy. This study is conducted at the University Hospital Zurich. The results may contribute to a better understanding of the relationship between the gut microbiome, metabolic regulation, inflammation, and cardiovascular disease, and may inform the design of future randomized clinical trials.

Conditions

Coronary Artery Disease; Type 2 Diabetes Mellitus (T2DM)

Keywords

Fecal Microbiota Transplantation; Gut Microbiome; Microbiome Modulation; Inflammation; Metabolic Regulation; Cardiometabolic Disease; Oral Microbiome; Vascular Function

Outcome Measures

Primary Outcomes (1)

• Change from baseline to 6 months in gut microbiome composition

  Gut microbiome composition will be assessed using sequencing-based analysis of stool samples.

  Baseline and 6 months

Study Arms (1)

Fecal Microbiota Transplantation

EXPERIMENTAL

Participants assigned to this arm will undergo fecal microbiota transplantation (FMT) administered via colonoscopy. FMT will be performed according to established clinical procedures and institutional standards. The intervention aims to modulate the gut microbiome in patients with type 2 diabetes mellitus and stable coronary artery disease.

Biological: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation BIOLOGICAL

Fecal microbiota transplantation (FMT) involves the transfer of processed stool from a carefully screened healthy donor into the gastrointestinal tract of a recipient. In this study, FMT will be administered via colonoscopy according to established clinical procedures and institutional standards. The intervention is intended to modulate the gut microbiome.

Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤75 years Diagnosis of type 2 diabetes mellitus Stable coronary artery disease Platelet count ≥50 × 10⁹/L within 2 days prior to FMT Hemoglobin ≥8.5 g/dL within 2 days prior to FMT International normalized ratio (INR) ≤1.5 within 2 days prior to FMT Willingness to undergo fecal microbiota transplantation (FMT) via colonoscopy Signed informed consent

You may not qualify if:

• Pregnancy or breastfeeding Women of childbearing potential not using adequate contraception Acute coronary syndrome within 12 months Requirement for dual antiplatelet therapy Relevant moderate or severe valvular heart disease Severe kidney dysfunction (estimated GFR \<30 mL/min) Significant liver dysfunction Contraindications to colonoscopy or FMT Systemic steroid or immunosuppressive therapy Antibiotic therapy within 3 months Ongoing infectious disease Active malignancy Participation in another interventional study Life expectancy \<12 months Inability to provide informed consent
• Healthy participants ≥18 years and \<60 years Eligibility for stool donation according to institutional donor screening procedures Negative donor screening results Signed informed consent
• History of gastrointestinal disease History of metabolic, autoimmune, or chronic inflammatory disease History of infectious disease Recent antibiotic therapy High-risk behavior for transmissible diseases Contraindications to colonoscopy Pregnancy or breastfeeding

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus, Type 2; Inflammation

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

CH (1)