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COMPLETED
NCT07640490
EARLY_PHASE1

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

Sponsor: Henan Provincial People's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-08-02

Completion Date

2026-05-02

Last Updated

2026-06-10

Healthy Volunteers

Yes

Interventions

DRUG

C Group

Continuous oral administration of probiotics

DRUG

P Group

Take a placebo, which looks no different from a probiotic agent

Locations (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, China