NCT07497932

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Mar 2026Dec 2026

Study Start

First participant enrolled

March 19, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

March 23, 2026

Last Update Submit

March 23, 2026

Conditions

Cardiovascular SurgeryCardiovascular Disease

Keywords

Gut microbiota-derived metabolitesMetabolomicsCardiovascular diseaseNutritional interventionMass spectrometry

Outcome Measures

Primary Outcomes (4)

  • Trimethylamine-N-oxide

    Gut microbiota-derived metabolites

    From enrollment to the end of intervention at 3 weeks

  • Phenylacetylglutamine

    Gut microbiota-derived metabolites

    From enrollment to the end of intervention at 3 weeks

  • P-cresyl sulfate

    Gut microbiota-derived metabolites

    From enrollment to the end of intervention at 3 weeks

  • Indoxyl sulfate

    Gut microbiota-derived metabolites

    From enrollment to the end of intervention at 3 weeks

Study Arms (2)

Probiotic group

EXPERIMENTAL

Received standard postoperative care with probiotic supplementation

Other: probiotic supplementation intervention

Placebo group

PLACEBO COMPARATOR

Received standard postoperative care with placebo supplementation

Other: Placebo supplementation intervention

Interventions

probiotic supplementation interventionOTHER

probiotic supplementation will be administered, while participants continue undergoing standard postoperative care

Probiotic group
Placebo supplementation interventionOTHER

Undergo routine standard postoperative care with placebo intervention

Placebo group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled to undergo cardiovascular surgery
  • Completed preoperative clinical and imaging evaluations
  • Willing to provide informed consent
  • Willing to receive potential probiotic supplementation

You may not qualify if:

  • Use of antibiotics, probiotics, or other treatments affecting gut microbiota within 4 weeks
  • History of major gastrointestinal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Ke-Yun Chao, PhD

    Fu Jen Catholic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke-Yun Chao, PhD

CONTACT

+886-905-301-879C00152@mail.fjuh.fju.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

March 19, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)