Pathogenesis of Pediatric Obsessive-compulsive Disorder: Based on the Microbiota-gut-brain Axis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06754319

Enrollment

125

Registered

2024-12-31

Start date

2024-08-24

Completion date

2027-12-31

Last updated

2026-08-03

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

Conditions

Obsessive-Compulsive Disorder, Tic Disorder

Keywords

microbiota-gut-brain axis, pediatric OCD, microbiome

Brief summary

This study aims to investigate the characteristics of the microbiota-gut-brain axis in pediatric patients with obsessive-compulsive disorder (OCD) through performing an integrated analysis of gut microbiota, serum metabolomics, neuroimaging and electroencephalography (EEG), conducted before and after treatment with selective serotonin reuptake inhibitors (SSRIs). The results will be compared with those of pediatric OCD paitents comorbid with tic disorder (TD) and healthy controls. The findings are expected to further elucidate the potential pathogenesis of OCD, providing a theoretical basis for identifying novel clinical intervention targets and optimizing treatment strategies.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Years to 17 Years

Healthy volunteers

Yes

Inclusion criteria

We recruited outpatient children and adolescents with OCD confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (4th edition). The following inclusion and

Exclusion criteria

were also applied: Inclusion Criteria: (1) 7-17 years old, (2) Y-BOCS score ≥16, (3) with or without a history of TD, (4) Drug-naïve or drug-free for 8 weeks, (5) Wechsler IQ score ≥ 80.

Design outcomes

Primary

Measure	Time frame	Description
Changes in the diversity and composition of the microbiome before and after drug treatment.	Before and after treatment with SSRIs for 12 weeks	The diversity (including alpha-diversity and beta-diversity) and composition will be measured in OCD patients and OCD patients with TD before and after drug treatment, and the results will be compared with those of healthy controls.

Countries

China

Contacts

CONTACTZhen Wang, PhD, MD

wangzhen@smhc.org.cn+86 34773516

PRINCIPAL_INVESTIGATORZhen Wang, PhD, MD

Shanghai Mental Health Center

Outcome results