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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07640490

Enrollment

150

Registered

2026-06-10

Start date

2025-08-02

Completion date

2026-05-02

Last updated

2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Depression

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.

Interventions

DRUGC Group

Continuous oral administration of probiotics

DRUGP Group

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026