Effects of Probiotics on the Gut-brain Axis in Children

March 5, 2026 updated by: Probi AB

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Placebo in a sachet
Active Comparator: Probiotics
Dietary supplement: Probiotics
Probiotics in a sachet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Conner's Continuous Performance test-3 (CPT-3) hit reaction time (HRT) block change score
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Probi AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEB24100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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