Gut Microbiome and Serum Metabolome Alterations in ADHD Patients

Completed

• Conditions: Attention-deficit/Hyperactivity Disorder

• Registration Number: NCT03447223
• Lead Sponsor: Xijing Hospital

Brief Summary

Host-microbe interactions play a key role in brain development and function and in the etiology of neurodevelopmental disorders. Attention-deficit/hyperactivity disorder (ADHD) is a heterogeneous disorder that affects 1 in 20 children and results in poor life-time outcomes. However, the etiology of ADHD is unclear and its diagnosis and treatment are still challenging. Different factors reported to be associated with the risk of developing ADHD and/or linked to different ADHD manifestations have also been linked to shifts in gut microbiota composition, suggesting a link between the microbiota and the disorder. Here, we will perform a metagenome-wide association study and serum metabolomics profiling in a cohort of control and ADHD, 6-15 years, Chinese individuals. We aim to identify ADHD-associated gut microbial species linked to changes in circulating metabolites. We also aim to find the possible intervention strategy in ADHD by targeting the gut microbiota.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-21
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-27
• Study Start: 2018-03-20
• Primary Completion: 2020-02-27
• Study Completion: 2020-05-27
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

Diagnoses of the children with ADHD were made in Xijing Hospital according to criteria described in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Children with ADHD had an IQ score above 70.

Exclusion Criteria

Children who had a past history of or were currently affected by neurological diseases, including convulsive disorders or brain damage; or who had any evidence of comorbid psychiatric conditions, such as Tourette's syndrome, IQ below 70, pervasive developmental disorder (autism), bipolar disorder, psychosis, language difficulties or learning disorders (reading disorders, mathematics disorders and disorders of written expression).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ADHD-associated gut microbial species alterations	2018-2020	Gut metagenome analysis with fecal samples

Secondary Outcome Measures

Name	Time	Method
ADHD-associated circulating metabolites alterations	2018-2020	Circulation metabonomics analysis with serum samples

Trial Locations

Locations (1)

Department of Pediatrics, Xijing Hospital, the Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China