drugset / Trial / NCT07640490

Influence of Oral Probiotics on Anxiety and Depression in Adolescents After Non-cardiac and Non-gastrointestinal Surgeries: A Prospective, Double-blind, Placebo-controlled Study

NCT07640490 ↗

Phase 0 Completed 150 enrolled Henan Provincial People's Hospital
RandomizedParallel-groupDouble-blindPrevention

Summary

This study intends to conduct a prospective, double-blind, randomized, controlled trial. Adolescents aged 12-17 years old and American Society of Anesthesiologists (ASA) physical status I and II are selected as subjects. Oral probiotics is used as intervention before surgery, vital signs data, serum IL-1, IL-6, BDNF,5-HT and other inflammatory indicators are collected before surgery and after non-cardiac and non-gastrointestinal surgeries, and the incidence and degree of anxiety and depression are evaluated after non-cardiac and non-gastrointestinal surgeries. To determine the effect of esketamine on reducing anxiety and depression in adolescents after non-cardiac and non-gastrointestinal surgeries, and to provide an effective clinical basis for accelerating the rehabilitation of adolescents after non-cardiac and non-gastrointestinal surgeries.

Timeline

Start
2025-08-02
Primary completion
2026-05-02
Completion
2026-05-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Bifidobacterium Tetra-Strain Live Bacteria Tablets Other / unclassified — Oral