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Enrolling by Invitation

NCT Number: NCT04444362

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

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.

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Key information

Conditions

Cardiovascular Disease Cardiopulmonary Bypass Cardiovascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intestinal Microbiota Transplant (IMT) Capsules

Drug

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

Primary outcomes

  1. Acute Gastrointestinal Injury

    Time frame: 14 days after surgery

Secondary outcomes

  1. ΔSOFA

    Time frame: 7 days after surgery

    the difference between the mean total postoperative SOFA score and baseline score within 24 hours of surgery during the index admission

  2. 30-day mortality rate

    Time frame: 30 days after surgery

    defined as mortality within 30 days postoperatively in the hospital or anywhere after discharge;

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • Shanghai East Hospital of Tongji University
  • The First Affiliated Hospital of Guangzhou Medical University
  • West China Hospital

Registry information

Official study title

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

Acronym: PANDA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 23, 2020
Registry last updated
Jan 6, 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.

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