Recruiting NCT07459699
Effects of Probiotics on the Gut-brain Axis in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotics, Placebo.
- Who it may be relevant to
- Registry conditions: Attention Deficit Hyperactivity Disorder (ADHD). Basic parameters: 8 years — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomised, Placebo-controlled Pilot Study to Assess the Effects of Probiotics on the Gut-brain Axis in Children With Attention Deficit Hyperactivity Disorder
Overview
The effect of probiotics on the gut-brain axis in children with attention deficit hyperactivity disorder will be studied.
Interventions
- Dietary supplement Probiotics
Probiotics in a sachet - Dietary supplement Placebo
Placebo in a sachet
Primary outcome measures
- Conner's Continuous Performance test-3 (CPT-3) hit reaction time (HRT) block change score [Time frame: 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Department of Developmental and Behavioral Pediatrics & Child Health Care Xinhua Hospital — Shanghai
Identifiers
NCT: NCT07459699 · PEB24100