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RecruitingNCT07459699Updated Jul 7, 2026

Effects of Probiotics on the Gut-brain Axis in Children

An interventional study of Probiotics and Placebo in Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Probi AB. Recruiting at 1 site in China. Open to participants aged 8 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Probi AB · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
8 Years to 11 Years
Sex
All
01

Study summary

The effect of probiotics on the gut-brain axis in children with attention deficit hyperactivity disorder will be studied.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder (ADHD)
03

Who can participate

Ages eligible
8 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Probiotics

    Dietary Supplement: Probiotics

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementProbiotics

    Probiotics in a sachet

  • Dietary supplementPlacebo

    Placebo in a sachet

05

What researchers measure

Primary outcomes

  1. Conner's Continuous Performance test-3 (CPT-3) hit reaction time (HRT) block change score

    Time frame: 12 weeks

06

Study locations

1 of 1 sites recruiting
  • Department of Developmental and Behavioral Pediatrics & Child Health Care Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    Shanghai, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07459699
Lead sponsor
Probi AB
Responsible party
Sponsor
First posted
Mar 10, 2026
Start date
May 25, 2026
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 7, 2026

Study contacts

Feng Li, MD, PhD
Contact
lifeng0228@163.com
+86-021-25077027

Oversight

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

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