Gut Microbiome and Serum Metabolome Alterations in ADHD Patients

NCT ID: NCT03447223

Last Updated: 2021-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-20

Study Completion Date

2020-05-27

Brief Summary

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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

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Conditions

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Attention-deficit/Hyperactivity Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ADHD-patients

The children and adolescent 6-15 years old with ADHD. 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.

No interventions assigned to this group

Controls-healthy children

Age- and gender- matched healthy 6-15 years old children and adolescent.

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lize Xiong, M.D./Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Professor and President, Xijing Hospital

Locations

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

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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Sharma A, Couture J. A review of the pathophysiology, etiology, and treatment of attention-deficit hyperactivity disorder (ADHD). Ann Pharmacother. 2014 Feb;48(2):209-25. doi: 10.1177/1060028013510699. Epub 2013 Nov 1.

Reference Type RESULT
PMID: 24259638 (View on PubMed)

Aarts E, Ederveen THA, Naaijen J, Zwiers MP, Boekhorst J, Timmerman HM, Smeekens SP, Netea MG, Buitelaar JK, Franke B, van Hijum SAFT, Arias Vasquez A. Gut microbiome in ADHD and its relation to neural reward anticipation. PLoS One. 2017 Sep 1;12(9):e0183509. doi: 10.1371/journal.pone.0183509. eCollection 2017.

Reference Type RESULT
PMID: 28863139 (View on PubMed)

Evangelisti M, De Rossi P, Rabasco J, Donfrancesco R, Lionetto L, Capi M, Sani G, Simmaco M, Nicoletti F, Villa MP. Changes in serum levels of kynurenine metabolites in paediatric patients affected by ADHD. Eur Child Adolesc Psychiatry. 2017 Dec;26(12):1433-1441. doi: 10.1007/s00787-017-1002-2. Epub 2017 May 19.

Reference Type RESULT
PMID: 28527020 (View on PubMed)

Related Links

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Other Identifiers

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KY20182002-1

Identifier Type: -

Identifier Source: org_study_id

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