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

Sponsor
University of Zurich
Study ID
NCT07421947
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

First listed
Feb 19, 2026
Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Fecal Microbiota Transplantation
    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.

Primary Outcome Measure

Change from baseline to 6 months in gut microbiome composition [ Time Frame: Baseline and 6 months ]

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