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

Study acronym: PANDA
StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026
    • Start date: Jan 1, 2021 to Jan 1, 2025
    • Primary endpoint revised
    • Collaborators: 4 to 3
    v5
  2. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised at 5 of 5 sites
    v4
  3. Enrollment target: 300 to 500v3 Show 8 more changesShow less
    • Primary endpoint revised
    • Study sites: 1 to 5
    • Start date changed from estimate of Jul 1, 2022 to Jan 1, 2021
    • Interventions: Inspiratory Muscle Training (Device) to Intestinal Microbiota Transplant (IMT) Capsules (Drug)
    • Secondary endpoints: 1 to 2
    • Collaborators expanded, about 20 words
    • Study title expanded, about 7 words
    • Eligibility criteria shortened, about 1 word
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Dec 31, 2022 to Dec 31, 2025
    • Start date: Jul 1, 2020 to Jul 1, 2022
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04444362
Lead Sponsor Nanjing Medical University
Collaborators: Shanghai East Hospital of Tongji University, West China Hospital, The First Affiliated Hospital of Guangzhou Medical University
Conditions
(from sponsor)		 Cardiovascular Disease, Cardiopulmonary Bypass
Related terms Cardiovascular Diseases
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov