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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Depression
• Intervention / Treatment: Drug: C Group; Drug: P Group

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Henan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 8 years ≤ age ≤17 years;
• Patients who plan to undergo elective surgery under general anesthesia, and the operation time is 1-2 hours;
• ASA grade I-II
• The body mass index falls within the normal range, which is 18.5 - 23.9 kg/m2.

Exclusion Criteria:

• The patient has psychological disorders, including but not limited to bipolar affective disorder.
• Eating disorder
• No informed consent form
• Due to certain serious diseases, one needs to take medication for a long period of time.
• Personality disorder
• Has undergone or needs to undergo gastrointestinal surgery
• Have taken antibiotics or probiotics within the past 8 weeks
• Pure vegetarian diet

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous oral administration of probiotics（Bifidobacterium Tetra-Strain Live Bacteria Tablets）; Selincon	Drug: C Group; Continuous oral administration of probiotics
Placebo Comparator: Take a placebo, which looks no different from a probiotic agent	Drug: P Group; Take a placebo, which looks no different from a probiotic agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety scale scores after surgery during 2 month	Hamilton Anxiety Rating Scale (HAMA)：The lower the score, the better the result	2 months
Depression scale scores after surgery during 2 month	Beck Depression Inventory (BDI)：The lower the score, the better the result	2 months

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2025
• Primary Completion (Actual): May 2, 2026
• Study Completion (Actual): May 2, 2026

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: June 6, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HenanGY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No