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NCT Number: NCT07459699

Effects of Probiotics on the Gut-brain Axis in Children

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

Recruiting

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Key information

Conditions

Attention Deficit Hyperactivity Disorder (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotics

Dietary Supplement

Probiotics in a sachet

Placebo

Dietary Supplement

Placebo in a sachet

Primary outcomes

  1. Conner's Continuous Performance test-3 (CPT-3) hit reaction time (HRT) block change score

    Time frame: 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Li, MD, PhD

CONTACT

[email protected]

+86-021-25077027

Sponsors and collaborators

Lead sponsor

Probi AB

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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