Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352, Taiwan
Location status: Recruiting
Recruiting
NCT Number: NCT07497932
Nutritional Effects in Cardiovascular Surgery
This study aims to investigate the distribution of gut microbiota-derived metabolites, and to evaluate whether postoperative nutritional intervention can modulate the gut-heart metabolic axis, thereby improving metabolic profiles and clinical outcomes.
Recruiting
Interested in participating?
Request InfoKey information
Age range
50 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Background： Cardiovascular diseases remain the leading cause of mortality worldwide. Recent research has highlighted the role of gut microbiota and its metabolites-such as trimethylamine-N-oxide, phenylacetylglutamine, and p-cresyl sulfate-in the pathogenesis of cardiovascular disease through mechanisms involving inflammation, oxidative stress, and vascular dysfunction. However, little is known about the actual distribution of these metabolites in human cardiac tissues or their correlation with circulating levels. No clinical studies to date have systematically examined both tissue and blood samples in this context.
Methods： Preoperative blood samples and intraoperative cardiac tissue specimens will be collected. Both targeted and untargeted metabolomics analyses will be performed using mass spectrometry to detect key gut microbiota-derived metabolites. A subset of patients will receive postoperative probiotic supplementation. Serial blood will be collected to monitor changes in the metabolome and gut microbial composition.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Scheduled to undergo cardiovascular surgery
- Completed preoperative clinical and imaging evaluations
- Willing to provide informed consent
- Willing to receive potential probiotic supplementation
Exclusion criteria
- Use of antibiotics, probiotics, or other treatments affecting gut microbiota within 4 weeks
- History of major gastrointestinal disease
Treatment and study plan
probiotic supplementation intervention
Otherprobiotic supplementation will be administered, while participants continue undergoing standard postoperative care
Placebo supplementation intervention
OtherUndergo routine standard postoperative care with placebo intervention
Primary outcomes
-
Trimethylamine-N-oxide
Time frame: From enrollment to the end of intervention at 3 weeks
Gut microbiota-derived metabolites
-
Phenylacetylglutamine
Time frame: From enrollment to the end of intervention at 3 weeks
Gut microbiota-derived metabolites
-
P-cresyl sulfate
Time frame: From enrollment to the end of intervention at 3 weeks
Gut microbiota-derived metabolites
-
Indoxyl sulfate
Time frame: From enrollment to the end of intervention at 3 weeks
Gut microbiota-derived metabolites
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Fu Jen Catholic University
Other
Registry information
Official study title
Nutritional Intervention in the Modulation of Postoperative Metabolism in Cardiovascular Surgery
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Mar 27, 2026
- Registry last updated
- Mar 27, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Recruiting
The Effects of a 6-week Pre-operative Administration of a Microbiome Modulator "WellBiome" Versus Placebo on Cardiac Surgical Outcomes and NHS Cost Savings.
NCT07483502
Cardiovascular Diseases, Cardiovascular Diseases (CVD)
Hull, East Riding Of Yorkshire, United Kingdom
View Trial Details
Recruiting
Appropriateness of Hemostatic Agent Use in Cardiovascular Surgery (HAEMOVAX)
NCT07699016
Cardiac Surgery, Cardiovascular Surgery
Milan, MI, Italy
View Trial Details
Recruiting
Fascial Plane Blocks In Cardiac Surgery
NCT07622823
Cardiovascular Surgery, Postoperative Analgesia
Antalya, Turkey (Türkiye)
View Trial Details
Recruiting
AI Model for Assessing Cardiac Surgeons' Techniques
NCT06739005
Artificial Intelligence (AI), CABG
Beijing, Beijing Municipality, China
View Trial Details