Given the high prevalence of migraine worldwide and the lack of absolute treatment for it, we designed the current double blind, placebo-controlled trial to investigate the effects of 8-week supplementation with Protexin Synbiotic / placebo on duration, severity and frequency of migraine attacks as well as the number of analgesics used by patients.
The inclusion criteria for participating in the study are as follows: consuming any type of fortified foods with probiotics in the last two months while exclusion criteria are taking any antipsychotic and antibiotic medications in the last two months .
The study population consists of 100 patients of which 25 chronic and 25 episodic migraineurs will receive two capsules of protexin synbiotic supplements each day and 25 chronic and 25 episodic migraineurs will receive 2 capsules of placebo daily for 8 weeks. We will ask from all participants to keep up their routine medical treatment and normal diet without any change during the study. The efficacy of the intervention will be assessed using MIDAS and VAS in addition to measuring changes in frequency and severity of migraine obtained from headache diaries of patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201706239157N6
Registration date:2017-07-26, 1396/05/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-26, 1396/05/04
Registrant information
Name
Prof Mansoureh Togha
Name of organization / entity
Neurology department, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 2052
Email address
toghae@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research Institute, Shaheed Beheshti University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-07-06, 1396/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Synbiotic Supplementation on the Migraine Headache Characteristics in Adults
Public title
Effects of Synbiotic Supplementation on Migraine Headache
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in the study; Age range between 18 to 60 years old; Diagnosis of chronic and episodic migraine headache according to the International Classification of Headache Disorders, 3rd edition (ICHD3 beta) criteria; Passing more than three months from migraine diagnosis; Migraine headache with more than 15 attacks per month for chronic migraine patients; Migraine headache with 3-15 attacks per month for episodic migraine patients; Not taking a synbiotic supplement or foods which fortified by Synbiotic two months before entering the study.
Exclusion criteria: Taking anti-psychotic drugs and/or antibiotic drugs during 2 months before the study; Pregnancy (or having a planned pregnancy); Lactation; Unwillingness to participate or continue the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research In
Street address
West Arghavan, Farahzadi BLV, Shahrak Gharb
City
Tehran
Postal code
Approval date
2016-08-27, 1395/06/06
Ethics committee reference number
IR.SBMU.nnftri.Rec.1395.66
Health conditions studied
1
Description of health condition studied
Chronic and Episodic Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
severity of migraine headache
Timepoint
before and two months after the intervention
Method of measurement
headache diary and examination by neurologist
2
Description
frequency of migraine attacks per month
Timepoint
before and two months after the intervention
Method of measurement
headache diary and examination by neurologist
3
Description
duration of migraine headache
Timepoint
before and two months after the intervention
Method of measurement
headache diary and examination by neurologist
Secondary outcomes
1
Description
the number of abortive drugs taken
Timepoint
before and two months after the intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Synbiotic Group:
Of 100 migraine patients, 25 subjects with chronic migraine and 25 subjects with episodic migraine will receive 2 capsules of protexin synbiotic supplement daily for 8 weeks. The supplement constituents are as fallows : Lactobacillus Casei, Lactobacillus Rhamnosus, Streptococcus thermophiles, Bifidobacterium brevis, Lactobacillus acidophilus, Bifidobacterium lehman, Lactobacillus bulgaricus, Fructooligosaccharides (FOS) and Synbiotic culture media.
Category
Treatment - Drugs
2
Description
Control Group:
Of 100 migraine patients, 25 subjects with chronic migraine and 25 subjects with episodic migraine will receive 2 capsules of placebo with the same smell and taste as protexin supplement for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital, Headache Clinic and Headache Research Center
Full name of responsible person
Maryam Seifi
Street address
Sina Hospital, Hasan Abad Sq., Imam Khomeini Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Morteza Abdollahi
Street address
West Arghavan, Farahzadi BLV, Shahrak Gharb
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research In
Full name of responsible person
Dr Soodeh Razeghi Jahromi
Position
Assistant professor
Other areas of specialty/work
Street address
West Arghavan, Farahzadi BLV, Shahrak Gharb
City
Tehran
Postal code
Phone
+98 21 22357
Fax
Email
razeghi@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research In
Full name of responsible person
Dr. Soodeh Razeghi Jahromi
Position
PhD in Nutritional sciences
Other areas of specialty/work
Street address
West Arghavan, Farahzadi BLV, Shahrak Gharb
City
Tehran
Postal code
Phone
+98 21 22357
Fax
West Arghavan, Farahzadi BLV, Shahrak Gharb
Email
razeghi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Headache Department, Iranian Center of Neurological Research,Tehran University of Medical Sciences
Full name of responsible person
Prof Mansoureh Togha
Position
Professor of Neurology
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Sq., Imam Khomeini Ave.
City
Tehran
Postal code
1136746911
Phone
+98 21 22357
Fax
+98 21 6634 8553
Email
toghae@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)