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Gut Microbiome and Serum Metabolome Alterations in ADHD Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03447223
Acronym
ADHD
Enrollment
207
Registered
2018-02-27
Start date
2018-03-20
Completion date
2020-05-27
Last updated
2021-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention-deficit/Hyperactivity Disorder

Keywords

Attention-deficit/hyperactivity disorder, circulating metabolites, metagenome

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.

Interventions

None listed

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
ADHD-associated gut microbial species alterations2018-2020Gut metagenome analysis with fecal samples

Secondary

MeasureTime frameDescription
ADHD-associated circulating metabolites alterations2018-2020Circulation metabonomics analysis with serum samples

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026