Protective Effect of Probacine Against Negative Gut Metabolism and Organ Dysfunction After Cardiovascular Surgery (PANDA IV)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intestinal Microbiota Transplant (IMT) Capsules.
- Who it may be relevant to
- Registry conditions: Cardiovascular Disease, Cardiopulmonary Bypass. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Protective Effect of Probacine Against Negative Gut Metabolism and Organ Dysfunction After Cardiovascular Surgery: A Randomized Controlled Trial
Overview
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.
Interventions
- Drug Intestinal Microbiota Transplant (IMT) Capsules
Intestinal Microbiota Transplant (IMT) Capsules were administered 7 days preoperatively and 14 days postoperatively.
Primary outcome measures
- Acute Gastrointestinal Injury [Time frame: 14 days after surgery]
Secondary outcome measures (2)
- ΔSOFA [Time frame: 7 days after surgery]
- 30-day mortality rate [Time frame: 30 days after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
China · 5 centers
- Beijing Anzhen Hospital — Beijing
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
- The First Affiliated Hospital of Nanjing Medical University — Nanjing
- West China Hospital of Sichuan University — Chengdu
- Shanghai East Hospital, Tongji University — Shanghai
Identifiers
NCT: NCT04444362 · PANDA IV