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 | Completed Early Phase 1

• 1 other identifier: HenanGY
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Continuous oral administration of probiotics（Bifidobacterium Tetra-Strain Live Bacteria Tablets）

EXPERIMENTAL

Selincon

Drug: C Group

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

PLACEBO COMPARATOR

Drug: P Group

Interventions

C Group DRUG

Continuous oral administration of probiotics

Continuous oral administration of probiotics（Bifidobacterium Tetra-Strain Live Bacteria Tablets）

P Group DRUG

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

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

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 10, 2026
• Study Start: August 2, 2025
• Primary Completion: May 2, 2026
• Study Completion: May 2, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

CN (1)