Gut Microbiome and Serum Metabolome Alterations in ADHD Patients

Attention-deficit/Hyperactivity Disorder Clinical Trial

— ADHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03447223
• Other study ID #: KY20182002-1
• Status: Completed
• Start date: March 20, 2018
• Est. completion date: May 27, 2020

Study information

• Verified date: August 2021
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: May 27, 2020
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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).

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-deficit/Hyperactivity Disorder
• Hyperkinesis

Locations

Country	Name	City	State
China	Department of Pediatrics, Xijing Hospital, the Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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):e0183 — View 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):14 — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD-associated gut microbial species alterations	Gut metagenome analysis with fecal samples	2018-2020
Secondary	ADHD-associated circulating metabolites alterations	Circulation metabonomics analysis with serum samples	2018-2020

External Links

•   Wikipedia