NCT04958460

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2020

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

April 6, 2023

Status Verified

April 1, 2023

Enrollment Period

2.8 years

First QC Date

April 23, 2021

Last Update Submit

April 5, 2023

Conditions

ADHDProbioticsGut MicrobiotaPsychiatryClinical Trial

Outcome Measures

Primary Outcomes (5)

  • Kiddie-Schedule for Affective Disorder and Schizophrenia-Epidemiological Ver- sion (K-SADS-E)

    screening

    At the baseline

  • The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)

    ADHD

    At the baseline

  • The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)

    ADHD

    2nd week

  • The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)

    ADHD

    4th week

  • The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)

    ADHD

    8th week

Study Arms (2)

Probiotics group

EXPERIMENTAL

Probiotics Candidates conditions excluded: 1. Patients with major mental or neurological diseases such as intellectual disability, autism group disorders, schizophrenia, severe depression, bipolar disorder, epilepsy, brain injury, etc. 2. Those who have serious gastrointestinal diseases, physiological diseases or genetic diseases that will affect the results of intestinal microflora assessment 3. Have received ADHD-related drug treatment (containing Methylphenidate or Atomoxetine) in the past month. 4. Have used antibiotics or edible probiotic-related products (including drops, tablets, capsules, bacterial powder) in the past month. 5. Participated in other clinical research in the past month. 6. Vegetarians or those currently undergoing special diet therapy. 7. Evaluation by the host is not suitable for entering the test.

Other: BF688

Control group

PLACEBO COMPARATOR

Placebo Candidates conditions excluded: 1. Patients with major mental or neurological diseases such as intellectual disability, autism group disorders, schizophrenia, severe depression, bipolar disorder, epilepsy, brain injury, etc. 2. Those who have serious gastrointestinal diseases, physiological diseases or genetic diseases that will affect the results of intestinal microflora assessment 3. Have received ADHD-related drug treatment (containing Methylphenidate or Atomoxetine) in the past month. 4. Have used antibiotics or edible probiotic-related products (including drops, tablets, capsules, bacterial powder) in the past month. 5. Participated in other clinical research in the past month. 6. Vegetarians or those currently undergoing special diet therapy. 7. Evaluation by the host is not suitable for entering the test.

Drug: Placebo

Interventions

PlaceboDRUG

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

Control group
BF688OTHER

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

Probiotics group

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ADHD

You may not qualify if:

  • Autism
  • Developmental Delay
  • Vegetarian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liang-Jen Wang

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Liang-Jen Wang

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Visiting Staff

Study Record Dates

First Submitted

April 23, 2021

First Posted

July 12, 2021

Study Start

May 14, 2020

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

April 6, 2023

Record last verified: 2023-04

Locations

TW(1)