Attention Deficit Hyperactivity Disorder (ADHD)NCT07459699
Effects of Probiotics on the Gut-brain Axis in Children
A study testing Probiotics in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Probi AB at 1 site in China.
Trial summary
The effect of probiotics on the gut-brain axis in children with attention deficit hyperactivity disorder will be studied. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females aged 8 - 11 years
- With mild ADHD symptoms
- Patient and parents (legal representatives) able and willing to participate in the research by complying with the protocol procedures
Who cannot join
- Metabolic disorder
- Severe chronic disease
- GI disorders found to be inconsistent with the conduct of the study by the investigator
- Neurological disorder involving central function (e.g., intellectual disability, autism spectrum disorder, epilepsy, narcolepsy)
- Currently treated with a medication with primary central nervous system activity or major psychiatric condition requiring hospitalization
- With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredients
Show all 10Show fewer
- Having taken prebiotic or probiotic treatment in the month prior to inclusion, or having taken antibiotics for more than one week in the 3 months prior to inclusion,
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
- Parents (legal representatives) presenting a psychological or linguistic incapability to sign the ICF,
- Parents (legal representatives) impossible to contact in case of emergency.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Developmental and Behavioral Pediatrics & Child Health Care Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
Official title: Randomised, Placebo-controlled Pilot Study to Assess the Effects of Probiotics on the Gut-brain Axis in Children With Attention Deficit Hyperactivity Disorder
The effect of probiotics on the gut-brain axis in children with attention deficit hyperactivity disorder will be studied.
- Being tested
- Probiotics, Placebo
- 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.
ProbioticsDietary supplement
Probiotics in a sachet
PlaceboDietary supplement
Placebo in a sachet
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Active comparator | Not described Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conner's Continuous Performance test-3 (CPT-3) hit reaction time (HRT) block change score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start25 May 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459699
- Sponsor's protocol ID
- PEB24100
- Status last verified
- Jul 2026
- First submitted
- 5 Mar 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Placebo-controlled Pilot Study to Assess the Effects of Probiotics on the Gut-brain Axis in Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT07459699
- Acronym / sponsor ID
- PEB24100
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Study start
- 25 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Mar 2026 (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.
The effect of probiotics on the gut-brain axis in children with attention deficit hyperactivity disorder will be studied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Active comparator | Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Males and females aged 8 - 11 years
- With mild ADHD symptoms
- Patient and parents (legal representatives) able and willing to participate in the research by complying with the protocol procedures
Key exclusion criteria (10 listed)
- Metabolic disorder
- Severe chronic disease
- GI disorders found to be inconsistent with the conduct of the study by the investigator
- Neurological disorder involving central function (e.g., intellectual disability, autism spectrum disorder, epilepsy, narcolepsy)
- Currently treated with a medication with primary central nervous system activity or major psychiatric condition requiring hospitalization
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 |
|---|---|---|
| ProbioticsProbiotics in a sachet | Dietary supplement | Probiotics |
| PlaceboPlacebo in a sachet | Dietary supplement | Placebo |
Primary outcome
Conner's Continuous Performance test-3 (CPT-3) hit reaction time (HRT) block change score
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Probi AB 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Li, MD, PhD (+86-021-25077027, lifeng0228@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conner's Continuous Performance test-3 (CPT-3) hit reaction time (HRT) block change score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.