Effects of Probiotics on the Gut-brain Axis in Children

ConditionAttention Deficit Hyperactivity Disorder (ADHD)

Trial statusNot yet recruiting

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 volunteers

Qualifiers

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 supplement
Probiotics in a sachet
Placebo
Dietary supplement
Placebo in a sachet

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: ProbioticsActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Conner's Continuous Performance test-3 (CPT-3) hit reaction time (HRT) block change score

Time frame

12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Probi AB

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: