Effect of Fingolimod with and without probiotic and vitamin E on the liver complications of in patients with relapsing-remitting multiple sclerosis: a double-blind randomized clinical trial
To assess the effect of Fingolimod with and without probiotics and vitamin E on the liver complications of in patients with relapsing-remitting multiple sclerosis
Design
This is a double-blind randomized clinical trial, phase II, in which 80 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with relapsing-remitting multiple sclerosis referring to the Imam Khomeini Clinic in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 20 to 40 years,
Relapsing-remitting multiple sclerosis,
Taking Fingolimod for at least 6 to 9 months,
Exclusion criteria:
Pregnancy or breastfeeding,
Immunodeficiency,
History of abdominal surgery,
The risk of mesenteric ischemia,
History of TB or HIV,
Hepatitis and liver disease,
Diabetes,
Kidney diseases,
High blood pressure
Intervention groups
Intervention group 1:
Fingolimod capsule 0.5 mg (manufactured by Razavi Pharmaceutical Co.) daily and LactoCare probiotic capsule (manufactured by Pardis Technology Park Co.) daily for 2 months
Intervention group 2:
Fingolimod capsule 0.5 mg (manufactured by Razavi Pharmaceutical Co.) daily and Perl Vitamin E 100 units (manufactured by Zahravi Pharmaceuticals Co.) daily for 2 Months
Intervention group 3:
Fingolimod capsule 0.5 mg (manufactured by Razavi Pharmaceutical Co.) daily and LactoCare probiotic capsule (manufactured by Pardis Technology Park Co.) daily and Perl Vitamin E 100 units (manufactured by Zahravi Pharmaceutical Co.) daily for 2 months
Control group:
Fingolimod capsule 0.5 mg (manufactured by Razavi Pharmaceutical Co.) daily for 2 months
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Fingolimod with and without probiotic and vitamin E on the liver complications of in patients with relapsing-remitting multiple sclerosis: a double-blind randomized clinical trial
Public title
Effect of Fingolimod with and without probiotic and vitamin E on the liver complications of in patients with relapsing-remitting multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20 to 40 years,
Relapsing-remitting multiple sclerosis,
Taking Fingolimod for at least 6 to 9 months,
Exclusion criteria:
Pregnancy or breastfeeding,
Immunodeficiency,
History of abdominal surgery or short bowel syndrome,
The risk of mesenteric ischemia,
History of TB or HIV,
Hepatitis and liver disease,
Diabetes,
Kidney diseases,
High blood pressure
Age
From 20 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs will be given in coded envelops. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions Thus, the trial will be run as triple-blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-12-21, 1398/09/30
Ethics committee reference number
IR.UMSHA.REC.1398.794
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Hepatic complication
Timepoint
Before and 2 months after the intervention
Method of measurement
With liver function tests (ALT, AST)
Secondary outcomes
1
Description
Gastric complication
Timepoint
Before and 2 months after the intervention
Method of measurement
By taking history
Intervention groups
1
Description
Intervention group 1: Fingolimod capsule 0.5 mg (manufactured by Razavi Pharmaceutical Co.) daily and LactoCare probiotic capsule (manufactured by Pardis Technology Park Co.) daily for 2 months
Category
Treatment - Drugs
2
Description
Intervention group 2:Fingolimod capsule 0.5 mg (manufactured by Razavi Pharmaceutical Co.) daily and Perl Vitamin E 100 units (manufactured by Zahravi Pharmaceuticals Co.) daily for 2 Months
Category
Treatment - Drugs
3
Description
Intervention group 3:Fingolimod capsule 0.5 mg (manufactured by Razavi Pharmaceutical Co.) daily and LactoCare probiotic capsule (manufactured by Pardis Technology Park Co.) daily and Perl Vitamin E 100 units (manufactured by Zahravi Pharmaceutical Co.) daily for 2 months
Category
Treatment - Drugs
4
Description
Control group:Fingolimod capsule 0.5 mg (manufactured by Razavi Pharmaceutical Co.) daily for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Clinic in Hamadan city
Full name of responsible person
Fatemeh Ahmadi
Street address
Imam Khomeini Clinic, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3832 1371
Email
fatemeh.ahmadi13731397@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Ahmadi
Position
Student of Pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fatemeh.ahmadi13731397@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Noori
Position
Pharmacologist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Fatemenouri1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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