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Clinical Trials/NCT03447223
NCT03447223
Completed
Not Applicable

Gut Microbiome and Serum Metabolome Alterations in Attention-deficit/Hyperactivity Disorder Patients

Xijing Hospital1 site in 1 country207 target enrollmentMarch 20, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Attention-deficit/Hyperactivity Disorder
Sponsor
Xijing Hospital
Enrollment
207
Locations
1
Primary Endpoint
ADHD-associated gut microbial species alterations
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 20, 2018
End Date
May 27, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Xijing Hospital
Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

ADHD-associated gut microbial species alterations

Time Frame: 2018-2020

Gut metagenome analysis with fecal samples

Secondary Outcomes

  • ADHD-associated circulating metabolites alterations(2018-2020)

Study Sites (1)

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