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Evaluation of multispecies probiotics on children and adolescents with migraine headaches during 3 months of treatment and a 3 months follow up period

Protocol summary

Study aim
Evaluation of multi-specious probiotics on prophylaxis of children and adolescents with common migraine headaches in 3 months therapeutic and 3 months follow up periods
Design
The clinical trial was randomized, parallel-group trial with blinded outcome assessment, designed for 54 patients.
Settings and conduct
Participants are selected according to inclusion criteria and after signing of the consent, will be divided randomly into 3 similar groups of prebiotics, prebiotics and vitamin D and placebo . Clinical findings, scales and questioners will be evaluated monthly . Blood sampling will be performed at the beginning and after 3 months of study . As a double-blind study, participants and evaluators are unaware of the substance's nature. After 3 months of therapy the patients will be followed for next 3 months .
Participants/Inclusion and exclusion criteria
6-18 years old patients with common migraine, normal vitamin D level, no underlying neurologic disease as well as medication, no use of antibiotics or probiotics in 2 recent weeks, Fill out the consent form.
Intervention groups
Patients who fill the inclusion criteria are randomly classified into three following groups: receive probiotics, probiotics with vitamin D, and a placebo. Symptoms, examination, quality of life, and headache severity are mentioned monthly for three months. Inflammatory factors and intestinal permeability characteristics are studied by laboratory tests at the beginning and end of the study.
Main outcome variables
Evaluation of multi-specious probiotics on intensity and frequency of headaches and quality of life of children and adolescents with common migraine .

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110628006907N17
Registration date: 2022-05-21, 1401/02/31
Registration timing: prospective

Last update: 2022-05-21, 1401/02/31
Update count: 0
Registration date
2022-05-21, 1401/02/31
Registrant information
Name
Mahmoudreza Ashrafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6612 9252
Email address
ashrafim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of multispecies probiotics on children and adolescents with migraine headaches during 3 months of treatment and a 3 months follow up period
Public title
The prophylactic effect of probiotics on children and adolescents with migraine headache
Purpose
Prevention
Inclusion/Exclusion 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:
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
Age
From 6 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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 .
Placebo
Used
Assignment
Parallel
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 .

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No 226, Central organization of Tehran University of Medical Sciences, Ghods Street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-04-20, 1401/01/31
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401..803

Health conditions studied

1

Description of health condition studied
Migraine headache
ICD-10 code
G43.019
ICD-10 code description
Migraine without aura, intractable, without status migrainosus

Primary outcomes

1

Description
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

2

Description
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

3

Description
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 outcomes

1

Description
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)

2

Description
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)

3

Description
Drug adverse effect
Timepoint
Any time during the study
Method of measurement
Ask from participants and parents

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Treatment - Drugs

3

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Children's Medical Center Hospital
Full name of responsible person
Mahmoud Reza Ashrafi
Street address
Children's Medical Center Hospital, No 62, Gharib Street, end of keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6612 9252
Fax
+98 21 6612 9252
Email
ashrafim@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotohee
Street address
Sixth floor, Central bulding of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
55
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Farabiotic Company
Full name of responsible person
Mohammad Mohammadi
Street address
Tehran, at the end of North Kargar Street, next to the University of Tehran dormitory, Center for the Development of Pharmaceutical Technology Units, No. 1462
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8098 3588
Email
info@farabiotic.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Farabiotic Company
Proportion provided by this source
45
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bita Heirati Asbagh
Position
Pediatric Neurology Fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Children's Medical Center Hospital, No 62, Gharib Street, end of keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6692 9234
Fax
+98 21 6612 9252
Email
Heirati.bita@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahmoud Reza Ashrafi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Children's Medical Center Hospital, No 62, Gharib Street, End of Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6612 9252
Fax
+98 21 6612 9252
Email
ashrafim@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Rezaei
Position
Pediatric Neurologist
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Children's Medical Center Hospital, No 62, Gharib Street, End of Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6612 9252
Email
zahra.rezaii84@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data would be available as long as the deidentification process is completed.
When the data will become available and for how long
Six months after data publication, it would be available with no limitation.
To whom data/document is available
Researchers of governmental or private research centers, researchers of University research centers, Knowledge-based companies,
Under which criteria data/document could be used
Data/ document is available for other research or academic centers to run a relevant study.
From where data/document is obtainable
All documents could be used in other research and academic institutes providing a comprehensive reference mentioned.
What processes are involved for a request to access data/document
Requesting by an email providing the data/document's application/s
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