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Gut Microbiome and Serum Metabolome Alterations in ADHD Patients (ADHD)

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ClinicalTrials.gov Identifier: NCT03447223
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : August 27, 2021
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Study Description
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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.

Condition or disease
Attention-deficit/Hyperactivity Disorder

Study Design
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Study Type : Observational
Actual Enrollment : 207 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Gut Microbiome and Serum Metabolome Alterations in Attention-deficit/Hyperactivity Disorder Patients
Actual Study Start Date : March 20, 2018
Actual Primary Completion Date : February 27, 2020
Actual Study Completion Date : May 27, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. ADHD-associated gut microbial species alterations [ Time Frame: 2018-2020 ]
    Gut metagenome analysis with fecal samples


Secondary Outcome Measures :
  1. ADHD-associated circulating metabolites alterations [ Time Frame: 2018-2020 ]
    Circulation metabonomics analysis with serum samples


Biospecimen Retention:   Samples With DNA
whole blood samples: serum metabolomics analyses; faeces: gut metagenome analyses

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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).

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447223


Locations
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China, Shaanxi
Department of Pediatrics, Xijing Hospital, the Fourth Military Medical University
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
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Principal Investigator: Lize Xiong, M.D./Ph.D. Professor and President, Xijing Hospital
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03447223    
Other Study ID Numbers: KY20182002-1
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xijing Hospital:
Attention-deficit/hyperactivity disorder
circulating metabolites
metagenome
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
 Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases