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