Protocol summary
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Study aim
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The effect of synbiotic supplements on inflammatory status, oxidative stress, intestinal permeability, clinical symptoms and mood in women with migraine
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Design
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A randomized controlled clinical trial with parallel groups, double-blind, randomized
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Settings and conduct
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The present study is a double-blind, randomized, parallel clinical trial. The target population includes those with migraines referred to the khorshid Clinic and Imam Musa Sadr Clinic who are diagnosed according to the criteria of the International Headache Society (HIS) by a neurologist . Split and study for 12 weeks. Before and after the intervention, severity of headache, frequency of headache and duration of headache, serum Zonulin level, serum nitric oxide level, serum Hs-CRP level, Total antioxidant capacity, Total oxidant status, depression, stress, anxiety and quality of life of migraine patients will be measured. To double-blind this study, all capsules were coded as A and B prior to study initiation.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients who agree to participate in the study
Diagnosis of migraine by a neurologist according to ICHD-3
Aged between 20 to 50 years old
Exclusion criteria: Non-compliance with dietary recommendations and supplements(Use less than 80% of the prescribed supplement)
Reaction and sensitivity to the prescribed supplement
Lack of referral in different stages of study
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Intervention groups
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افراد گروه مداخله(N=40): روزانه دو عدد کپسول سین بیوتیک 500 میلی گرم نیم ساعت قبل از وعده شام و نهار برای 12 هفته
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Main outcome variables
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Migraine severity score; migraine frequency; duration of migraine; Hs-CRP level, Zonulin level, nitric oxide level, total antioxidant capacity, total oxidant status, depression, stress, anxiety, quality of life
General information
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Reason for update
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grammar errors in title
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20121216011763N45
Registration date:
2020-04-22, 1399/02/03
Registration timing:
prospective
Last update:
2020-11-16, 1399/08/26
Update count:
1
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Registration date
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2020-04-22, 1399/02/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-07-22, 1399/05/01
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Expected recruitment end date
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2021-05-22, 1400/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of synbiotic supplementation on inflammatory status, oxidative stress, intestinal permeability, clinical features and mood in women with migraine
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Public title
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The effect of synbiotic supplement in migraine
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients who agree to participate in the study
Diagnosis of migraine by a neurologist according to ICHD-3
Aged between 20 to 50 years old
Exclusion criteria:
Non-compliance with dietary recommendations and supplements(Use less than 80% of the prescribed supplement)
Reaction and sensitivity to the prescribed supplement
Lack of referral in different stages of study
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Age
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From 20 years old to 50 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will conduct based on https://www.sealedenvelope.com/simple-randomiser/v1/lists. Each block have capacity for 4 subjects. Then, within each block, subjects will be randomly assigned to treatment or placebo. Random assignment will be done using a random chain will be extracted from the site.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This study is a double blind clinical trial (participant, researcher). synbiotic supplement and placebo (identical from color, shape and odor) will be packaged in similar boxes and the researcher and patients will not be informed of the contents of the packs until the end of the study.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-04, 1398/12/14
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1398.752
Health conditions studied
1
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Description of health condition studied
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Migraine
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ICD-10 code
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G43.0
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ICD-10 code description
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Migraine without aura
Primary outcomes
1
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Description
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Migraine symptoms (severity, frequency, duration of migraine)
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Questionnaire (Visual analogue scale (VAS) and Clinical examination)
2
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Description
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Serum levels of Zonulin
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA) kits
3
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Description
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Serum levels of High sensitive C-reactive protein (Hs-CRP)
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA) kits
Secondary outcomes
1
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Description
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Depression, stress, anxiety
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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DASS-21questionnaire
2
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Description
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Quality of Life in Migraine Patients
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Migraine –Specific Quality of Life(MSQ)questionnaire
3
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Description
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Serum Nitric Oxide
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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biochemical kit of KiaZist Co.
4
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Description
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Total antioxidant capacity
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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biochemical kit of KiaZist Co.
5
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Description
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Total oxidant status
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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biochemical kit of KiaZist Co.
Intervention groups
1
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Description
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Intervention group: Two capsule of synbiotic 500 mg daily half an hour before dinner and lunch for 12 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Two capsule of starch 500 mg daily half an hour before dinner and lunch for 12 weeks
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Major part of information will be available for population.
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When the data will become available and for how long
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12 months after publication
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To whom data/document is available
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Available for people working in academic institutions
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Under which criteria data/document could be used
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To conduct similar studies
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From where data/document is obtainable
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askari@mui.ac.ir
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What processes are involved for a request to access data/document
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The data will be sent as soon as possible, after receiving the request
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Comments
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