Clinical trial NCT03447223: Gut Microbiome and Serum Metabolome Alterations in ADHD Patients
Official title: Gut Microbiome and Serum Metabolome Alterations in Attention-deficit/Hyperactivity Disorder Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention-deficit/Hyperactivity Disorder
Keywords: Attention-deficit/hyperactivity disorder
circulating metabolites
metagenome
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 207
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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).

Primary outcomes:
measure: ADHD-associated gut microbial species alterations
timeFrame: 2018-2020
Secondary outcomes:
measure: ADHD-associated circulating metabolites alterations
timeFrame: 2018-2020
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Pediatrics, Xijing Hospital, the Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Professor and President, Xijing Hospital
name: Lize Xiong, M.D./Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.