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

NCT07421947 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-19

No results posted yet for this study

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

Interventions

BIOLOGICAL

Fecal Microbiota Transplantation

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.

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07421947 on ClinicalTrials.gov