NCT07419659

Brief Summary

The study aims to evaluate whether postbiotics supplementation can improve ADHD symptoms, such as mood and sleep, in children. Furthermore, salivary biochemical profiles will be analyzed and dietary habits will be recorded to further explore the effects and mechanisms of action of postbiotics. Research process: 80 subjects who meet the admission conditions will be recruited within three years after IRB approval. They will take the research capsules (postbiotics) in an open label design study and complete the 8-week intervention plus 4 weeks follow up trial period.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
30mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Feb 2026Dec 2028

First Submitted

Initial submission to the registry

January 23, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 25, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

January 23, 2026

Last Update Submit

February 24, 2026

Conditions

ADHD - Attention Deficit Disorder With HyperactivityADD/ADHD

Keywords

ADDADHDfood supplements

Outcome Measures

Primary Outcomes (3)

  • Total Scores of Clinical Symptoms-Swanson, Nolan, and Pelham Rating Scale-4th Edition(SNAP-IV)

    The SNAP-IV is used assess symptoms of ADHD (Attention Deficit Hyperactivity Disorder) in children and adolescents. It consists of a series of questions that rate the severity of behaviors such as inattention, hyperactivity, and impulsivity, based on teacher and parent observations. The scale includes both parent and teacher versions, allowing for a comprehensive view of a child's behavior in different environments. The scoring system rates each behavior on a 4-point scale from 0 (never or rarely) to 3 (very often), and higher total scores indicate more significant ADHD symptoms. The results help clinicians in diagnosing ADHD and monitoring treatment progress.

    Baseline, 8th week and 12th week

  • Total Scores of Child Behavior Checklist

    This parent-reported questionnaire is a comprehensive assessment tool for identifying behavioral and emotional problems in children. It includes 100 items (scored 0-3) covering multiple domains such as anxiety, depression, social issues, and aggressive behavior, providing a detailed profile of the child's psychological functioning. The score ranges from 0-200, with a higher score representing higher concern of behavior problems.

    Baseline, 8th week and 12th week

  • Changes of Sleep and Appetite

    Use Fitbit and sleep diary to monitor the bedtime resistance, sleep resistance, sleep disordered breathing, night-waking, daytime sleepiness and sleep onset delay. Diet diary and InBody to monitor the change of appetite and body weight.

    Baseline, 8th week and 12th week

Secondary Outcomes (6)

  • Parenting Stress Index, Fourth Edition Short Form , PSI-4-SF

    Baseline and 8th week

  • Visual Analogue Scale for Gastrointestinal Symptoms, VAS-GI

    Baseline and 8th week

  • Clinical Global Impressions-Severity, CGI-S and Clinical Global Impressions-Improvement, CGI-I

    Baseline, 8th week and 12th week

  • The Patient Global Impression of Change (PGI-C)

    8th week and 12th week

  • Conners Continuous Performance Test 3rd Edition, Conners CPT 3

    Baseline and 8th week

  • +1 more secondary outcomes

Study Arms (1)

Postbiotics

EXPERIMENTAL

Dietary Supplement

Dietary Supplement: postbiotics

Interventions

postbioticsDIETARY_SUPPLEMENT

The participants will consume 2 capsules of postbiotics supplement per day for 8 weeks

Postbiotics

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 6-13 years old
  • Has been diagnosed with ADHD and is taking medication regularly or has not yet started medication.

You may not qualify if:

  • Have taken antibiotics within one month or are receiving antibiotic treatment
  • Have used probiotic products in powder, capsule or tablet form within one month (including yogurt, yogurt, Yakult and other related foods)
  • Those who are allergic to lactic acid bacteria products
  • Obtain a disability certificate
  • Participating in other human research
  • Determined unsuitable by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan, 404332, Taiwan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 23, 2026

First Posted

February 19, 2026

Study Start

February 25, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

TW(1)