Protective Effect of Probacine Against Negative Gut Metabolism and Organ Dysfunction After Cardiovascular Surgery (PANDA IV) (PANDA)

Protective Effect of Probacine Against Negative Gut Metabolism and Organ Dysfunction After Cardiovascular Surgery: A Randomized Controlled Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiovascular Disease; Cardiopulmonary Bypass
• Intervention / Treatment: Drug: Intestinal Microbiota Transplant (IMT) Capsules

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai East Hospital, Tongji University
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Beijing Anzhen Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou Medical University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital of Nanjing Medical University
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intestinal Microbial Transformation (IMT); 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; Intestinal Microbiota Transplant (IMT) Capsules were administered 7 days preoperatively and 14 days postoperatively.
No Intervention: Control; The control group received standard treatment and care, including prophylactic antibiotics , fluid therapy, and enteral nutrition supports.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Acute Gastrointestinal Injury	14 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ΔSOFA	the difference between the mean total postoperative SOFA score and baseline score within 24 hours of surgery during the index admission	7 days after surgery
30-day mortality rate	defined as mortality within 30 days postoperatively in the hospital or anywhere after discharge;	30 days after surgery

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Collaborators: West China Hospital; The First Affiliated Hospital of Guangzhou Medical University; Shanghai East Hospital of Tongji University
• Investigators: Study Director: Guo-liang Fan, Shanghai East Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 20, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Gut microbiota
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pharmaceutical Preparations; Therapeutics; Dosage Forms; Biological Therapy; Fecal Microbiota Transplantation; Capsules
• Other Study ID Numbers: PANDA IV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No