Effects of Probiotics on the Gut-brain Axis in Children

Recruiting · NCT07459699 · Interventional (participants receive a specific treatment) · Lead sponsor: Probi AB

Interventions studied

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

Age range

8 Years to 11 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

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.

1 location listed.

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