The prophylactic effect of probiotics on children and adolescents with migraine headache

Phase 2

Conditions: Migraine headache.
Migraine without aura, intractable, without status migrainosus
G43.019

Registration Number: IRCT20110628006907N17

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 54

Inclusion Criteria

Suffering from common migraine (headache without aura) according to the International Headache society criteria (IHS)
Indication of migraine prophylactic treatment (at least four migraine attacks per 4 weeks; or severe dysfunction in daily and school activities during prospective baseline phase)
Normal vitamin D level
No systemic or underlying disease
Other medication that affect the nervous system, such as anti- seizure medication, should not to be used simultaneously
No antibiotic consumption in the recent 2 weeks
Informed consent of parents

Exclusion Criteria

Underlying systemic or neurologic disease
Simultaneous consumption of drugs such as anti-seizure medication that make an impact on nervous system
Anti-biotic consumption (oral or parenteral) in the recent 2 weeks
Another probiotic consumption in the recent 2 weeks
The patient/parents do not agree to participate in the study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of multi-specious probiotics on headache intensity. Timepoint: At the beginning of the study followed by monthly evaluation in a three months interventional period and follow up. Method of measurement: Questionnaire of Visual analogue scale (VAS) for more than 10 years and Visual Pain Scale less than 10 years.;Evaluation of multi-specious probiotics on headache frequency. Timepoint: At the beginning of the study followed by monthly evaluation in a three months interventional period and follow up. Method of measurement: Questionnaire of frequency of each attack in a month.;Evaluation of multi-specious probiotics on quality of life. Timepoint: At the beginning of the study followed by monthly evaluation in a three months interventional period and follow up. Method of measurement: PEDMIDAS Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Evaluation of multi-specious probiotics on inflammatory factors in blood including of PCAP,CGRP. Timepoint: At the beginning and end of the study. Method of measurement: Laboratory Evaluation (kit).;Evaluation of multi-specious probiotics on intestinal permeability characters With LPS. Timepoint: At the beginning and end of the study. Method of measurement: Laboratory Evaluation (kit).;Drug adverse effect. Timepoint: Any time during the study. Method of measurement: Ask from participants and parents.