NCT04444362

Brief Summary

Cardiovascular diseases (CVDs) continue to be the primary cause of illness and death globally, emphasizing the pressing requirement for efficient prevention methods. Recent studies indicate that the gut microbiome plays a vital role in maintaining cardiovascular health, affecting the pathophysiological mechanisms related to CVDs. The potential therapeutic strategies for primary care practitioners included the modulation of the gut microbiome through dietary changes, prebiotics, and probiotics. The aim of this study was to investage the effect of gut microbiome modulation on clinical outcomes after cardiac surgery.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
enrolling by invitation

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 Progress67%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

June 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
4.5 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2 years 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

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

June 20, 2020

Last Update Submit

January 3, 2026

Conditions

Cardiovascular DiseaseCardiopulmonary Bypass

Keywords

Gut microbiota

Outcome Measures

Primary Outcomes (1)

  • Acute Gastrointestinal Injury

    14 days after surgery

Secondary Outcomes (2)

  • ΔSOFA

    7 days after surgery

  • 30-day mortality rate

    30 days after surgery

Study Arms (2)

Intestinal Microbial Transformation (IMT)

EXPERIMENTAL

The Intestinal Microbial Transformation (IMT) group received Probacine, in addition to standard treatment and care, including prophylactic antibiotics , fluid therapy, and enteral nutrition supports.

Drug: Intestinal Microbiota Transplant (IMT) Capsules

Control

NO INTERVENTION

The control group received standard treatment and care, including prophylactic antibiotics , fluid therapy, and enteral nutrition supports.

Interventions

Intestinal Microbiota Transplant (IMT) CapsulesDRUG

Intestinal Microbiota Transplant (IMT) Capsules were administered 7 days preoperatively and 14 days postoperatively.

Intestinal Microbial Transformation (IMT)

Eligibility Criteria

Age18 Years - 90 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult men and women;
  • Cardiovascular surgery;
  • Agree to participate in the study and sign the informed consent form.

You may not qualify if:

  • Pregnant women;
  • Patients with preexisting psychotic disorders;
  • Decline to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Shanghai East Hospital, Tongji University

Shanghai, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Fecal Microbiota TransplantationCapsules

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsDosage FormsPharmaceutical Preparations

Study Officials

  • Guo-liang Fan

    Shanghai East Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Due to the nature of this research, we could not keep the participants blind to group assignment, but the study staff and statistical analyses were all blind to patient allocation during datacollection.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator of Cardio-Thoracic Surgery

Study Record Dates

First Submitted

June 20, 2020

First Posted

June 23, 2020

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)