Impact of Probiotics on Children With ADHD

NCT06348121 | Completed

• 1 other identifier: WK2024003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Clinical symptoms of ADHD

  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.

  56 days

Study Arms (1)

Probiotic group

EXPERIMENTAL

5B CFU/strip/day WecProB, before meal

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

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

Probiotic group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.;

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (1)

• Niu Q, Wang W, Liang Y, Fang S, Wan L, Yang G. Efficacy and Safety of a Probiotic Mixture Containing Bifidobacterium animalis subsp. lactis BLa80 and Lacticaseibacillus rhamnosus LRa05 in Children With Attention-Deficit/Hyperactivity Disorder. Mol Nutr Food Res. 2025 Nov;69(22):e70234. doi: 10.1002/mnfr.70234. Epub 2025 Sep 2.

  PMID: 40898729 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 4, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2024-04

Locations

CN (1)