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

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ClinicalTrials.gov Identifier: NCT03447223
Recruitment Status : Not yet recruiting
First Posted : February 27, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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, 3-15 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
Microtia

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Gut Microbiome and Serum Metabolome Alterations in Attention-deficit/Hyperactivity Disorder Patients
Estimated Study Start Date : February 28, 2018
Estimated Primary Completion Date : February 27, 2020
Estimated Study Completion Date : February 27, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
ADHD-patients
The children 3-15 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 3-15 years old children.



Primary Outcome Measures :
  1. ADHD-associated gut microbial species alterations [ Time Frame: 2018-2019 ]
    Gut metagenome analysis with fecal samples


Secondary Outcome Measures :
  1. ADHD-associated circulating metabolites alterations [ Time Frame: 2018-2019 ]
    Circulation metabonomics analysis with serum samples


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


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Ages Eligible for Study:   3 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).


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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


Contacts
Contact: Yan Li, M.D./Ph.D. +8602984774562-803 liyann@fmmu.edu.cn
Contact: Anqi Yin, M.D. +8602984771262 849249602@qq.com

Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: Lize Xiong, M.D./Ph.D. Professor and President, Xijing Hospital

Additional Information:
Publications of Results:
Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03447223     History of Changes
Other Study ID Numbers: KY20182002-1
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: January 2018

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:
Attention Deficit Disorder with Hyperactivity
Congenital Microtia
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Congenital Abnormalities