Pathogenesis of Pediatric Obsessive-compulsive Disorder: Based on the Microbiota-gut-brain Axis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-17
SponsorShanghai Mental Health Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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.
Trial population
Drug-naïve or drug-free pediatric patients with OCD, drug-naïve or drug-free pediatric OCD patients comorbid with TD, and healthy control.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
125 Participants
are grouped into 3 trial groupsGroup A: pediatric OCD patients
Group B: pediatric OCD patients comorbid with TD
Group C: healthy controls
Trial outcomes
Primary outcomes
1
Changes in the diversity and composition of the microbiome before and after drug treatment.
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.
Time frame
Before and after treatment with SSRIs for 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov