Attention Deficit Hyperactivity DisorderNCT06348121
Impact of Probiotics on Children With ADHD
A study testing Probiotic in people with Attention Deficit Hyperactivity Disorder, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of ADHD per DSM-5 criteria;
- Age 6-12 years, gender-neutral;
- IQ >70 on intelligence testing;
- Participant/guardian comprehension and voluntary consent.
Who cannot join
- 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.;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Probiotic
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The experimental phase of the study had last 56 days, and each patient will make 3 visits (d0, d28, d56).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | 5B CFU/strip/day WecProB, before meal Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Sep 2024
- Primary completion1 Dec 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348121
- Sponsor's protocol ID
- WK2024003
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40898729
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bifidobacterium Animalis Subsp. Lactis and Lacticaseibacillus Rhamnosus Mixture in Children With ADHD
- ClinicalTrials.gov ID
- NCT06348121
- Acronym / sponsor ID
- WK2024003
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Probiotic5B CFU/strip/day WecProB, before meal |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of ADHD per DSM-5 criteria;
- Age 6-12 years, gender-neutral;
- IQ >70 on intelligence testing;
- Participant/guardian comprehension and voluntary consent.
Key exclusion criteria (6 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticThe experimental phase of the study had last 56 days, and each patient will make 3 visits (d0, d28, d56). | Dietary supplement | Probiotic group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Derived from this study: PubMed 40898729Niu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Attention Deficit Hyperactivity Disorder, run by Wecare Probiotics Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical symptoms of ADHD (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06348121, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.