Multi-strain Probiotics for ADHD | NCT06226584

Studies
Multi-strain Probiotics for ADHD

NCT06226584

Sponsor

Tsyr-Huey Mental Hospital

Status

Unknown status

Last Update Posted

Jan 26, 2024Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Attention Deficit and Hyperactivity Disorders

Interventions

multiple-strain probiotics

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 3, 2024Actual

Primary Completion Date

Nov 30, 2024Estimated

Completion Date

Nov 30, 2024Estimated

First Submitted Date

Jan 13, 2024

First Submission Date that Met QC Criteria

Jan 23, 2024

First Posted Date

Jan 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2024

Last Update Posted Date

Jan 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Probiotics are widely used as supplement for various neurodevelopmental disorders. The mechanism of their therapeutic potential lies in the "gut-brain axis", a two-way communication pathway through the neuroendocrine system. In the past, there have been many experiments to study the possible efficacy of probiotics in patients with ADHD. Although some studies have shown that probiotics can improve ADHD symptoms, most studies have used behavioral rating scales to evaluate. As a result, it is susceptible to informant bias. Standardized attentional tests and quantitative electroencephalogram (qEEG) can provide more objective data and detect possible changes in brain networks. Such changes may precede behavioral phenotypes. Therefore, the purpose of this study is mainly to detect the therapeutic effect of multiple strains of probiotics in patients with attention deficit hyperactivity disorder by using standardized attention tests and quantified brain waves (qEEG).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
multiple-strain probiotics	Experimental		Dietary Supplement: multiple-strain probiotics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
multiple-strain probiotics	Dietary Supplement	Juice HA capsule which contains more than one strain of probiotics	multiple-strain probiotics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Swanson, Nolan and Pelham Chinese (SNAP) rating scales	for behavioral symptoms of ADHD, the minimum and maximum values (0-78), higher scores mean a worse outcome	every one month for 3 months
Conners' Continuous Performance Test 3rd Edition	a task-oriented computerised assessment of attention-related problems in individuals aged 8 years and older	pre- and post-intervention (3 months)
quantitative electroencephalogram	measurement of brain wave patterns and coherence	pre- and post-intervention (3 months)

Secondary Outcomes

Measure	Description	Time Frame
adverse events	any adverse events occurred during study	every one month for 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A patient is eligible for the study if all of the followings apply:

8-11 children diagnosed with ADHD by board certified pediatric psychiatrist according to DSM-5 (assessment tool using SNAP criteria, at least 6/9 symptoms of inattention and/or hyperactivity/impulsivity (≧2/3 on each severity scale) on parents' and teachers' observation)
On stable psychotropic mediations (i.e. no change in dose of methylphenidate or antipsychotics) for past 8 weeks

Exclusion Criteria:

Any patient meeting any of the exclusion criteria will be excluded from study participation:

Patients with major mental or neurological diseases such as intellectual disability, autism group disorders, schizophrenia, severe depression, bipolar disorder, epilepsy, brain injury, etc.
Those who have serious gastrointestinal diseases, physiological diseases or genetic diseases.
Have used antibiotics or edible probiotic-related products (including drops, tablets, capsules, bacterial powder) in the past month.
Participated in other clinical research in the past month.
Vegetarians or those currently undergoing special diet therapy.
Evaluation by the pediatric psychiatrist not suitable for entering the test

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
YU-SHIAN CHENG, MDPhD	Contact	00886978173901		n043283@gmail.com

Name	Affiliation	Role
YU-SHIAN CHENG, MDPhD	Tsyr-Huey Mental Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Tsyr-HueyMentalHospital	Recruiting	Kaohsiung City		831	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided