Probiotics for children with ADHD: gut-brain axis impact

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial investigates the effects of probiotic supplementation on the gut-brain axis in children with mild ADHD symptoms. Participants aged 8 to 11 will be randomized to receive either probiotics or placebo, with outcomes focused on ADHD-related behaviors and any gut-related changes. The study uses a controlled, parallel design to compare the probiotic product against placebo while monitoring safety and tolerability. Exclusion criteria limit participation to children without significant metabolic, neurological, or severe systemic conditions, and without recent antibiotic or probiotic use. The research is conducted under the leadership of Probi AB with the Xinhua Hospital affiliate in Shanghai.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Feng Li, MD, PhD
• Email: lifeng0228@163.com
• Phone: +86-021-25077027

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.