Cardiovascular SurgeryNCT07497932
Nutritional Effects in Cardiovascular Surgery
A study testing probiotic supplementation intervention in people with Cardiovascular Surgery and Cardiovascular Disease, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cardiovascular Surgery, Cardiovascular Disease
- What is being tested?
- probiotic supplementation intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo cardiovascular surgery
- Completed preoperative clinical and imaging evaluations
- Willing to provide informed consent
- Willing to receive potential probiotic supplementation
Who cannot join
- Use of antibiotics, probiotics, or other treatments affecting gut microbiota within 4 weeks
- History of major gastrointestinal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
Ke-Yun Chao, PhD, +886-905-301-879, ck_qq@hotmail.con
About this study
Official title: Nutritional Intervention in the Modulation of Postoperative Metabolism 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.
Read the detailed description
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.
- Conditions
- Cardiovascular Surgery, Cardiovascular Disease
- Being tested
- probiotic supplementation intervention, Placebo supplementation intervention
- Keywords
- Gut microbiota-derived metabolites, Metabolomics, Cardiovascular disease, Nutritional intervention, Mass spectrometry
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic supplementation interventionOther
probiotic supplementation will be administered, while participants continue undergoing standard postoperative care
Placebo supplementation interventionOther
Undergo routine standard postoperative care with placebo intervention
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Received standard postoperative care with probiotic supplementation Receives: Other: probiotic supplementation intervention |
| Placebo group | Placebo comparator | Received standard postoperative care with placebo supplementation Receives: Other: Placebo supplementation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trimethylamine-N-oxide
Gut microbiota-derived metabolites
Measured: From enrollment to the end of intervention at 3 weeks
Phenylacetylglutamine
Gut microbiota-derived metabolites
Measured: From enrollment to the end of intervention at 3 weeks
P-cresyl sulfate
Gut microbiota-derived metabolites
Measured: From enrollment to the end of intervention at 3 weeks
Indoxyl sulfate
Gut microbiota-derived metabolites
Measured: From enrollment to the end of intervention at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start19 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Yun, Chao, Fu Jen Catholic University
- Investigators
- Ke-Yun Chao, PhD, Principal investigator, Fu Jen Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497932
- Sponsor's protocol ID
- FJUH114505
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention in the Modulation of Postoperative Metabolism in Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT07497932
- Acronym / sponsor ID
- FJUH114505
- Conditions
- Cardiovascular Surgery, Cardiovascular Disease
- Keywords
- Gut microbiota-derived metabolites, Metabolomics, Cardiovascular disease, Nutritional intervention, Mass spectrometry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Other: probiotic supplementation interventionReceived standard postoperative care with probiotic supplementation |
| Placebo group | Placebo comparator | Other: Placebo supplementation interventionReceived standard postoperative care with placebo supplementation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to undergo cardiovascular surgery
- Completed preoperative clinical and imaging evaluations
- Willing to provide informed consent
- Willing to receive potential probiotic supplementation
Key exclusion criteria (2 listed)
- Use of antibiotics, probiotics, or other treatments affecting gut microbiota within 4 weeks
- History of major gastrointestinal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotic supplementation interventionprobiotic supplementation will be administered, while participants continue undergoing standard postoperative care | Other | Probiotic group |
| Placebo supplementation interventionUndergo routine standard postoperative care with placebo intervention | Other | Placebo group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ke-Yun Chao, PhD principal investigator
Fu Jen Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic supplementation intervention in people with Cardiovascular Surgery and Cardiovascular Disease, run by Fu Jen Catholic University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ke-Yun Chao, PhD (+886-905-301-879, C00152@mail.fjuh.fju.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trimethylamine-N-oxide (time frame: From enrollment to the end of intervention at 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.