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Completed

NCT Number: 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

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.

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Key information

Conditions

Anxiety Depression

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C Group

Drug

Continuous oral administration of probiotics

P Group

Drug

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

Primary outcomes

  1. Anxiety scale scores after surgery during 2 month

    Time frame: 2 months

    Hamilton Anxiety Rating Scale (HAMA)：The lower the score, the better the result

  2. Depression scale scores after surgery during 2 month

    Time frame: 2 months

    Beck Depression Inventory (BDI)：The lower the score, the better the result

Sponsors and collaborators

Lead sponsor

Henan Provincial People's Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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