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IRCT20110628006907N17 IRCT 2022-05-21 Tehran University of Medical Sciences The prophylactic effect of probiotics on children and adolescents with migraine headache Evaluation of multispecies probiotics on children and adolescents with migraine headaches during 3 months of treatment and a 3 months follow up period 2022-06-22 anticipated 54 Complete https://irct.ir/trial/63173 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Monthly visits and study of questionnaires and scales for clinical symptoms . Paraclinical laboratory exams to evaluate inflammatory factors and intestinal permeability characters at the beginning of study and after 3 months of receiving drug or placebo , Randomization description: According to formula of sample size, the patients are randomly allocated into three groups of receiving probiotics, combination of probiotics and vitamin D and control group of placebo treatment, by using a balanced block randomization technique. To achieve the goal, they were divided into 6 and 9 blocks. All subjects were randomly allocated by online randomization software to generate random-number sequences. {Sealed Envelope Ltd. 2015. Create a blocked randomization list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 15 Dec 2015]}. The coordinator and physician/s who evaluate inclusion /exclusion criteria and patient registration are completely blind, Blinding description: Considering the study as a double-blind one, the placebo was presented to the control group is similar to probiotics in appearance, taste, and administration roles. The patients, recruiter and the physicians who evaluate the patients during the study are blind to drug or placebo . 2-3 Migraine headache. 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. Clinical aspects, examination, headache severity and quality of life are measured at the beginning of study and then monthly. After that, children are followed for 3 months without any medication. Blood samples to evaluate the inflammatory factors as well as intestinal permeability characters are drawn at the beginning and end of the study. Intervention 2: The 2nd Intervention group: The children who suffers from common migraine headache, are going to be treated by a sachet/ day as a combination of probiotics and vitamin D, made by Farabiotic company for three months. Clinical aspects, examination, headache severity and quality of life are measured at the beginning of study and then monthly. After that, children are followed for 3 months without any medication. Blood samples to evaluate the inflammatory factors as well as intestinal permeability characters are drawn at the beginning and end of the study. Intervention 3: Control group: The children who suffers from common migraine headache, are going to be treated by a sachet/ day of placebo made by Farabiotic company for three months. Clinical aspects, examination, headache severity and quality of life are measured at the beginning of study and then monthly. After that, children are followed for 3 months without any medication. Blood samples to evaluate the inflammatory factors as well as intestinal permeability characters are drawn at the beginning and end of the study. Yes - There is a plan to make this available What will be shared: All data would be available as long as the deidentification process is completed. When: Six months after data publication, it would be available with no limitation. To whom: Researchers of governmental or private research centers, researchers of University research centers, Knowledge-based companies, Conditions: Data/ document is available for other research or academic centers to run a relevant study. Where to obtain: All documents could be used in other research and academic institutes providing a comprehensive reference mentioned. How to obtain: Requesting by an email providing the data/document's application/s Comments:
public Bita Heirati Asbagh
Children's Medical Center Hospital, No 62, Gharib Street, end of keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6692 9234 Heirati.bita@gmail.com Tehran University of Medical Sciences scientific Mahmoud Reza Ashrafi
Children's Medical Center Hospital, No 62, Gharib Street, End of Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6612 9252 ashrafim@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 6 years 18 years Both 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 G43.019 Migraine without aura, intractable, without status migrainosus Treatment - Drugs Treatment - Drugs Placebo 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. Clinical aspects, examination, headache severity and quality of life are measured at the beginning of study and then monthly. After that, children are followed for 3 months without any medication. Blood samples to evaluate the inflammatory factors as well as intestinal permeability characters are drawn at the beginning and end of the study. The 2nd Intervention group: The children who suffers from common migraine headache, are going to be treated by a sachet/ day as a combination of probiotics and vitamin D, made by Farabiotic company for three months. Clinical aspects, examination, headache severity and quality of life are measured at the beginning of study and then monthly. After that, children are followed for 3 months without any medication. Blood samples to evaluate the inflammatory factors as well as intestinal permeability characters are drawn at the beginning and end of the study. Control group: The children who suffers from common migraine headache, are going to be treated by a sachet/ day of placebo made by Farabiotic company for three months. Clinical aspects, examination, headache severity and quality of life are measured at the beginning of study and then monthly. After that, children are followed for 3 months without any medication. Blood samples to evaluate the inflammatory factors as well as intestinal permeability characters are drawn at the beginning and end of the study. 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. 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. Farabiotic Company Tehran University of Medical Sciences Farabiotic Company Approved 2022-04-20 Ethics committee of Tehran University of Medical Sciences No 226, Central organization of Tehran University of Medical Sciences, Ghods Street, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)