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Search / Trial NCT06754319

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

Launched by SHANGHAI MENTAL HEALTH CENTER · Dec 23, 2024

Trial Information

Current as of November 12, 2025

Enrolling by invitation

Keywords

Microbiota Gut Brain Axis Pediatric Ocd Microbiome

ClinConnect Summary

This study in Shanghai is exploring how the gut’s bacteria (the microbiota) and other body signals relate to pediatric obsessive-compulsive disorder (OCD), including kids who also have tic disorders. Researchers will compare three groups: children with OCD, children with OCD plus tic disorder, and healthy controls. They will collect stool samples, blood, brain MRI scans, and EEG data, then treat the OCD groups with standard care SSRIs for about 12 weeks to see how the gut microbiome changes before and after treatment and how these changes relate to brain signals and symptoms.

Participation is planned for about 125 children and teens aged 7 to 17 who have OCD with a Y-BOCS score of 16 or higher and who have not recently used OCD medications (or have been off meds for at least 8 weeks). They may or may not have tic disorders and must have an IQ of 80 or higher; certain medical conditions, recent antibiotics, or other factors may exclude them. The study is being run at Shanghai Mental Health Center and led by Zhen Wang. It is observational, meaning treatment with SSRIs (and antipsychotics if tic disorder is present) is given as part of routine care, while researchers observe microbiome, metabolomics, and brain data. The study is currently enrolling by invitation and is expected to continue through 2027; results are not yet available.

Gender

ALL

Eligibility 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.
  • Exclusion Criteria:
  • History of serious medical, neurological illness or other psychotic disorders other than OCD (tic disorder excepted).
  • Previous exposure to cognitive behavioral therapy (CBT) for OCD or TD.
  • serious suicide risk.
  • Has taken antibiotics, probiotics, prebiotics, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or immunosuppressants within the past 8 weeks.
  • Has a history of gastrointestinal diseases such as inflammatory bowel disease, irritable bowel syndrome, constipation, hemorrhoids, or a history of gastrointestinal surgery, or has a history of autoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus.
  • Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.

About Shanghai Mental Health Center

Shanghai Mental Health Center is a leading institution dedicated to advancing mental health research and treatment. As a prominent clinical trial sponsor, the center focuses on innovative therapeutic approaches and evidence-based practices to address a wide range of psychiatric disorders. With a multidisciplinary team of experts and state-of-the-art facilities, the center is committed to enhancing patient care through rigorous clinical trials that contribute to the understanding and management of mental health conditions. Its mission is to foster collaboration among researchers, clinicians, and patients to promote mental well-being and improve outcomes in mental health care.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Trial Officials

Zhen Wang, PhD, MD

Principal Investigator

Shanghai Mental Health Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported