Impact of Probiotics on Children With ADHD

This study investigates WecProB (Bifidobacterium animalis subsp. lactis and Lacticaseibacillus rhamnosus) to evaluate their potential to improve symptoms and safety in children with ADHD.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of ADHD per DSM-5 criteria;
Age 6-12 years, gender-neutral;
IQ >70 on intelligence testing;
Participant/guardian comprehension and voluntary consent.

Exclusion criteria

Those with a clear history of other serious neurological diseases, such as epilepsy, head trauma, encephalitis or meningitis, etc.;
Have taken antibiotics, probiotics or immunosuppressants within one month before starting the experiment;
Ongoing special diet, such as ketogenic diet, etc
BMI higher than the 90th percentile or lower than the 10th percentile for children of the same age and sex;
Those who have had symptoms of respiratory or digestive tract infection in the past month, such as fever, cough, diarrhea, etc.;
Those who have had inflammatory bowel disease in the past, such as ulcerative colitis, Crohn's disease, etc.;

Treatment and study plan

Probiotic

Dietary Supplement

The experimental phase of the study had last 56 days, and each patient will make 3 visits (d0, d28, d56).

Primary outcomes

Clinical symptoms of ADHD

Time frame: 56 days

The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2), was employed to assess the executive functioning deficits commonly associated with ADHD in children. The BRIEF-2 scale ranges from a minimum of 0 to a maximum of 300 points. Higher scores on the BRIEF-2 indicate greater executive dysfunction, meaning that a higher score reflects worse outcomes.

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

Efficacy of Bifidobacterium Animalis Subsp. Lactis and Lacticaseibacillus Rhamnosus Mixture in Children With ADHD

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Apr 4, 2024
Registry last updated: Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed