The Efficacy of Beneficial Intestinal Microbiota in the T... | NCT07092241

Studies
The Efficacy of Beneficial Intestinal Microbiota in the Treatment of Migraine and Its Mechanism: Basic and Clinical Studies

NCT07092241

Sponsor

National Taiwan University Hospital

Status

Active, not recruiting

Last Update Posted

Jul 29, 2025Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Pediatric Migraine

Interventions

microbiota
microbiota

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

Jul 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Mar 20, 2024Actual

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jul 8, 2025

First Submission Date that Met QC Criteria

Jul 28, 2025

First Posted Date

Jul 29, 2025Actual

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

Jul 28, 2025

Last Update Posted Date

Jul 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

pediatric migraine

Detailed Description

To explore the efficacy and pathogenesis of gut-brain axis by basic and clinical approach, The investigators will apply the candidate beneficial bacteria selected from the results of our previous clinical studies to the migraine animal model and will further conduct a clinical trial that investigates the efficacy of the commercial probiotics containing these candidate beneficial bacteria for the pediatric migraineurs to explore their therapeutic potential in treating migraine. The participants will keep headache diary and disability assessment by Pediatric Migraine Disability Assessment Score (PedMIDAS: 0-240) will be evaluated before and at the end of 12 weeks therapy. The investigators will also examine the effects of the protective bacteria clinically by measuring CGRP, a key biomarker of migraine, and proinflammatory cytokines before and after treatment by clinical approach, and explore these important markers on both the gut and brain ends in the migraine animal model to clarify the mechanism of gut-brain axis in migraine pathogenesis.

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
The placebo group	Placebo Comparator	Double set parallel	Dietary Supplement: microbiota
treated group	Active Comparator		Dietary Supplement: microbiota

Interventions

Name	Type	Description	Arm Group Labels	Other Names
microbiota	Dietary Supplement	Bifidobacterium breve and Bifidobacterium longum	The placebo group treated group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The efficacy of beneficial intestinal microbiota in the treatment of migraine and its mechanism: basic and clinical studies	evaluation of the efficacy: headache intensity (pain score: 0-10), frequency (headache times per week) and headache days per week as well as disability assessment by Pediatric Migraine Disability Assessment Score (PedMIDAS: 0-240). The listed outcome measures are all distinct clinical assessments related to migraine burden and are not derived from or dependent on variables such as weight or height. Each outcome is measured using its own standardized scale or unit and will be reported separately as specified in the protocol.	From enrollment to the end of treatment at 12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis with migraine

Exclusion Criteria:

Receiving antibiotic treatment for the past 2 weeks
Receiving probiotic treatment for the past one month
Multiple congenital anomalies, for instance, meningoencephalocele, chromosomal anomalies, and congenital intestinal atresia, etc.
Mental retardation that is difficult to describe the symptoms

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

The data will not be shared due to privacy concerns and the lack of participant consent for public data sharing. Additionally, the scope of the study does not include provisions for data sharing beyond the primary analyses.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064307	Microbiota

Ancestor Terms

ID	Term
D008827	Microbiological Phenomena
D058448	Biota
D044822	Biodiversity
D017753	Ecosystem

Browse Leaves

Not provided

Browse Branches

Not provided