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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 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-06-10

No results posted yet for this study

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.

Conditions

  • Anxiety Depression

Interventions

DRUG

C Group

Continuous oral administration of probiotics

DRUG

P Group

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

Sponsors & Collaborators

  • Henan Provincial People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07640490 on ClinicalTrials.gov