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Effect of Probiotics on ADHD

NCT04958460 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-04-06

No results posted yet for this study

Summary

Attention-Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder. Gut microbiome dysbiosis may be associated with the pathophysiology of ADHD. Investigators previously found the relative abundance of Sutterella stercoricanis were increased and Bifidobacterium bifidum were decreased in the ADHD group. Investigators hypothesize that ADHD patients receiving supplementary Bifidobacterium bifidum (Bf-688) is able to increase the proportion of Bf-688; inhibit the proportion of Sutterella; and improve ADHD symptoms.

Conditions

  • ADHD
  • Probiotics
  • Gut Microbiota
  • Psychiatry
  • Clinical Trial

Interventions

DRUG

Placebo

Administrated 1 packet of maltodextrin (as placebo of Bf-688) in the morning and evening

OTHER

BF688

Administrated 1 pack each morning and evening (5×109 CFUs per day)

Sponsors & Collaborators

  • Wang Liang-Jen

    lead OTHER

Principal Investigators

  • Liang-Jen Wang · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-14
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04958460 on ClinicalTrials.gov