NCT07092241

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Migraine

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	microbiota	Bifidobacterium breve and Bifidobacterium longum
DIETARY_SUPPLEMENT	microbiota	Bifidobacterium and Lactobacillus

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-03-20
• Completion: 2027-12-31
• First posted: 2025-07-29
• Last updated: 2025-07-29

Locations

1 site across 1 country: Taiwan