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Completed

NCT Number: NCT03447223

Gut Microbiome and Serum Metabolome Alterations in ADHD Patients

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.

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Key information

Conditions

Attention-Deficit/Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pediatrics, Xijing Hospital, the Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. ADHD-associated gut microbial species alterations

    Time frame: 2018-2020

    Gut metagenome analysis with fecal samples

Secondary outcomes

  1. ADHD-associated circulating metabolites alterations

    Time frame: 2018-2020

    Circulation metabonomics analysis with serum samples

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Acronym: ADHD

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2018
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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