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

Nanjing Medical University

Status: Invitation-only

Conditions: Cardiopulmonary Bypass; Cardiovascular Disease

Treatments: Drug: Intestinal Microbiota Transplant (IMT) Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT04444362

PANDA IV

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

500 participants in 2 patient groups

Intestinal Microbial Transformation (IMT)

Experimental group

Description:

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

Treatment:

Drug: Intestinal Microbiota Transplant (IMT) Capsules

Control

No Intervention group

Description:

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