Effects of Probiotics on the Gut-brain Axis in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-11
SponsorProbi AB
About this trial
The effect of probiotics on the gut-brain axis in children with attention deficit hyperactivity disorder will be studied.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotics
Dietary supplementProbiotics in a sachet
Placebo
Dietary supplementPlacebo in a sachet
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: ProbioticsActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Conner's Continuous Performance test-3 (CPT-3) hit reaction time (HRT) block change score
Time frame
12 weeks Source ClinicalTrials.gov