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

NCT07092241 | Active Not Recruiting

• 1 other identifier: 202207086RIND
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

pediatric migraine

Conditions

Pediatric Migraine

Keywords

pediatric migraine; gut-brain-axis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

The placebo group

PLACEBO COMPARATOR

Double set parallel

Dietary Supplement: microbiota

treated group

ACTIVE COMPARATOR

Dietary Supplement: microbiota

Interventions

microbiota DIETARY_SUPPLEMENT

Bifidobacterium breve and Bifidobacterium longum

The placebo group; treated group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• clinical diagnosis with migraine

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Interventions

Microbiota

Intervention Hierarchy (Ancestors)

Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double set parallel

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 29, 2025
• Study Start: January 1, 2023
• Primary Completion: March 20, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)