NCT07459699
Not yet recruiting
Not Applicable
Randomised, Placebo-controlled Pilot Study to Assess the Effects of Probiotics on the Gut-brain Axis in Children With Attention Deficit Hyperactivity Disorder
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Probi AB
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Conner's Continuous Performance test-3 (CPT-3) hit reaction time (HRT) block change score
Overview
Brief Summary
The effect of probiotics on the gut-brain axis in children with attention deficit hyperactivity disorder will be studied.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Dietary Supplement)
Probiotics
Active Comparator
Intervention: Probiotics (Dietary Supplement)
Outcomes
Primary Outcomes
Conner's Continuous Performance test-3 (CPT-3) hit reaction time (HRT) block change score
Time Frame: 12 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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