Migraine headache. Migraine without aura, intractable, without status migrainosus
Conditions
Interventions
Intervention 1: The 1st Intervention group: The children who suffers from common migraine headache, are going to be treated by a sachet/ day of probiotics made by Farabiotic company for three months.
Sponsors
Tehran University of Medical Sciences
Farabiotic Company
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBita Heirati Asbagh
Tehran University of Medical Sciences
Outcome results
None listed