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Effects of Probiotics on the Gut-brain Axis in Children | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Effects of Probiotics on the Gut-brain Axis in Children

Randomised, Placebo-controlled Pilot Study to Assess the Effects of Probiotics on the Gut-brain Axis in Children With Attention Deficit Hyperactivity Disorder

NCT07459699•Probi AB

View on ClinicalTrials.gov

Summary

The effect of probiotics on the gut-brain axis in children with attention deficit hyperactivity disorder will be studied.

Eligibility

Age

8 - 11 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females aged 8 - 11 years
•With mild ADHD symptoms
•Patient and parents (legal representatives) able and willing to participate in the research by complying with the protocol procedures

Exclusion Criteria

•Metabolic disorder
•Severe chronic disease
•GI disorders found to be inconsistent with the conduct of the study by the investigator
•Neurological disorder involving central function (e.g., intellectual disability, autism spectrum disorder, epilepsy, narcolepsy)
•Currently treated with a medication with primary central nervous system activity or major psychiatric condition requiring hospitalization
•With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredients
•Having taken prebiotic or probiotic treatment in the month prior to inclusion, or having taken antibiotics for more than one week in the 3 months prior to inclusion,
•Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
•Parents (legal representatives) presenting a psychological or linguistic incapability to sign the ICF,
•Parents (legal representatives) impossible to contact in case of emergency.

Locations (1)

Department of Developmental and Behavioral Pediatrics & Child Health Care Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Key Dates

Start Date

March 1, 2026

Primary Completion Date

October 1, 2027

Completion Date

October 1, 2027

Last Updated

March 10, 2026

Enrollment

ESTIMATED participants

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Probiotics

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

Contacts

Feng Li, MD, PhD

CONTACT

+86-021-25077027 lifeng0228@163.com

L-theanine and Paraxanthine for Cognitive Improvement in Adults With ADHD and ASD

NCT07189442

Attention Deficit Hyperactivity Disorder (ADHD)Autism Spectrum Disorder (ASD)

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COMPLETEDNA

Neuro-Nutrition to Support Physiological Function and Cognitive Skills in People With Down Syndrome, Autism Spectrum Disorder, and ADHD

NCT07165509

Down SyndromeAutism Spectrum Disorder+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of Probiotics on the Gut-brain Axis in Children

Inclusion Criteria

Exclusion Criteria

L-theanine and Paraxanthine for Cognitive Improvement in Adults With ADHD and ASD

Neuro-Nutrition to Support Physiological Function and Cognitive Skills in People With Down Syndrome, Autism Spectrum Disorder, and ADHD

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Internet-Based Behavioural Parent Training Intervention for Children With Attention Deficit/Hyperactivity Disorder

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