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

NCT ID: NCT07092241

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2027-12-31

Brief Summary

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pediatric migraine

Detailed Description

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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.

Conditions

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Pediatric Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double set parallel
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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The placebo group

Double set parallel

Group Type PLACEBO_COMPARATOR

microbiota

Intervention Type DIETARY_SUPPLEMENT

Bifidobacterium breve and Bifidobacterium longum

microbiota

Intervention Type DIETARY_SUPPLEMENT

Bifidobacterium and Lactobacillus

treated group

Group Type ACTIVE_COMPARATOR

microbiota

Intervention Type DIETARY_SUPPLEMENT

Bifidobacterium breve and Bifidobacterium longum

Interventions

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microbiota

Bifidobacterium breve and Bifidobacterium longum

Intervention Type DIETARY_SUPPLEMENT

microbiota

Bifidobacterium and Lactobacillus

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis with migraine

Exclusion Criteria

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

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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202207086RIND

Identifier Type: -

Identifier Source: org_study_id

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