Gut Microbiome and Serum Metabolome Alterations in ADHD Patients

NCT03447223 | Completed DMC

• 1 other identifier: KY20182002-1
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention-deficit/Hyperactivity Disorder

Keywords

Attention-deficit/hyperactivity disorder; circulating metabolites; metagenome

Outcome Measures

Primary Outcomes (1)

• ADHD-associated gut microbial species alterations

  Gut metagenome analysis with fecal samples

  2018-2020

Secondary Outcomes (1)

• ADHD-associated circulating metabolites alterations

  2018-2020

Study Arms (2)

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.

Controls-healthy children

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

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All subjects were drug-naive at the time of recruitment, and the ADHD tests were administered before the subjects were given any medication. The subjects will be recruited from Xijing Hospital and elementary and secondary schools in China.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

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

Xi'an, Shaanxi, 710032, China

Location

Related Publications (3)

• 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.

  PMID: 24259638 RESULT

• 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.

  PMID: 28863139 RESULT

• 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.

  PMID: 28527020 RESULT

Related Links

• Wikipedia

Biospecimen

Retention: SAMPLES WITH DNA

whole blood samples: serum metabolomics analyses; faeces: gut metagenome analyses

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Lize Xiong, M.D./Ph.D.

  Professor and President, Xijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: February 27, 2018
• Study Start: March 20, 2018
• Primary Completion: February 27, 2020
• Study Completion: May 27, 2020
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

CN (1)