NCT07421947Not yet recruiting
Effects of Fecal Microbiota Transplantation in Patients With Type 2 Diabetes and Coronary Artery Disease (CAD-Microbiome) - A Pilot Study
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 12 Feb 2026
- Start date
- Apr 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- University of Zurich
- Diseases
- Coronary artery disease, Type 2 diabetes
- NCT number
- NCT07421947
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Apr 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- 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
Who the study is looking for
- 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
- Healthy participants ≥18 years and \<60 years Eligibility for stool donation according to institutional donor screening procedures Negative donor screening results Signed informed consent
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.