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CompletedNCT06348121Updated Apr 4, 2025

Impact of Probiotics on Children With ADHD

An interventional study of Probiotic in Attention Deficit Hyperactivity Disorder, sponsored by Wecare Probiotics Co., Ltd.. Completed at 1 site in China. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Wecare Probiotics Co., Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder
03

In context

Attention Deficit Disorder with Hyperactivity

1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.

This study's enrollment of 50 is below the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Wecare Probiotics Co., Ltd. is the lead sponsor of 65 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.;
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Probiotic group

    5B CFU/strip/day WecProB, before meal

    Dietary Supplement: Probiotic

Interventions

  • Dietary supplementProbiotic

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

06

What researchers measure

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.

    Time frame: 56 days

07

Study locations

1 site
  • Chinese PLA General Hospital
    Beijing, Beijing 100000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06348121
Lead sponsor
Wecare Probiotics Co., Ltd.
Responsible party
Sponsor
First posted
Apr 4, 2024
Start date
Sep 1, 2024
Primary completion
Dec 1, 2024
Completion
Mar 1, 2025
Last update
Apr 4, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Wecare Probiotics Co., Ltd.

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