Impact of Probiotics on Children With ADHD

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

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Dietary supplement: Probiotic

Detailed Description

Randomized groups were given a combination of probiotics or placebo in addition to treatment with a consistent dose (1.2 mg/kg/d) of conventional ADHD medication (atomoxetine). The total length of the study is 12 weeks, and at weeks 0, 4, 8 and 12 weeks of the trial, the clinical symptoms of ADHD will be assessed using a scale. Blood and stool samples will be collected at weeks 0 and 12, and psychological tests will be performed. Nucleic acid sequencing technology was used to identify bacterial species in feces, and high-throughput 16S rRNA sequences were quickly obtained by sequencing, and fecal metabolites were analyzed.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic group; 5B CFU/strip/day WecProB, before meal	Dietary supplement: Probiotic; The experimental phase of the study had last 56 days, and each patient will make 3 visits (d0, d28, d56).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: WK2024003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No