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Recruiting NCT07459699

Effects of Probiotics on the Gut-brain Axis in Children

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Sex: All
Ages: 8 Years – 11 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Probi AB

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

Summary

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

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07459699). StuddyBuddy aggregates publicly available trial information.