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

Starting soon · Not applicable

Conditions studied: Coronary Artery Disease, Type 2 Diabetes Mellitus (T2DM)

In brief

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 facts

Study ID
NCT07421947
Run by
University of Zurich
People needed
30
Starts
2026-04-01
Expected to finish
2028-12-01
Last updated by the study team
2026-02-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.