Effects of Probiotics on the Gut-brain Axis in Children

Probi AB

Status

Not yet enrolling

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Probiotics

Study type

Interventional

Funder types

Industry

Identifiers

PEB24100

Details and patient eligibility

About

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

Enrollment

80 estimated patients

Sex

All

Ages

8 to 11 years old

Volunteers

No Healthy Volunteers

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.