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

N/AActive Not RecruitingNCT07092241

National Taiwan University Hospital30 enrolled

Overview

pediatric migraine

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pediatric Migraine

Interventions

microbiotaDIETARY_SUPPLEMENT

Bifidobacterium breve and Bifidobacterium longum

microbiotaDIETARY_SUPPLEMENT

Bifidobacterium and Lactobacillus

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

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.

Time frame: From enrollment to the end of treatment at 12 weeks

Data from ClinicalTrials.gov

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