The effects of synbiotic product on gut microbiota changes in patients with multiple sclerosis treated with dimethyl fumarate: A randomized, double-blind, placebo-control clinical trial
The effects of synbiotic product on gut microbiota changes in patients with multiple sclerosis treated with dimethyl fumarate: A randomized, double-blind, placebo-control clinical trial
Design
A Phase 3, randomized controlled parallel-group double-blind clinical trial involving 60 patients will be conducted. Randomization will be implemented utilizing a random block design.
Settings and conduct
Patients with MS referred to the MS clinic of Bo Ali Sina Educational
Center who meet the inclusion criteria and do not have the exclusion criteria are included in the study and are divided into two groups according to the randomization table and are evaluated for 6 months . The treating doctor, the patient and the evaluator are unaware of the type of therapeutic
Participants/Inclusion and exclusion criteria
Adults over 18 years of age with a recent diagnosis of Multiple Sclerosis or a first attack consistent with high-risk primary clinical syndrome based on the McDonald 2017 criteria, disability due to EDSS less than 4.5, and candidates for dimethyl fumarate were included in the study.
Also, people who have received systemic antibiotics in the last month, people who have received probiotic supplements in the last 3 month, people who have received omega-3 and antioxidants in the last month, and people who are pregnant and lactating are included are excluded from study.
Intervention groups
Familact or placebo capsules daily for 6 months
Main outcome variables
Alterations of pathogenic bacteria, Correlation with clinical manifestations of the disease, Adverse effects' profile of immunomodulatory medications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190804044429N12
Registration date:2024-07-06, 1403/04/16
Registration timing:registered_while_recruiting
Last update:2024-07-06, 1403/04/16
Update count:0
Registration date
2024-07-06, 1403/04/16
Registrant information
Name
Monireh Ghazaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 6864
Email address
ghazaeianm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-08-12, 1404/05/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of synbiotic product on gut microbiota changes in patients with multiple sclerosis treated with dimethyl fumarate: A randomized, double-blind, placebo-control clinical trial
Public title
The effects of synbiotic product on gut microbiota changes in patients with multiple sclerosis treated with dimethyl fumarate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults over 18 years of age with a recent diagnosis of MS or a first attack consistent with a high-risk primary clinical syndrome based on the McDonald 2017 criteria
Expanded disability status scale less than 4.5
Candidate for dimethyl fumarate
Exclusion criteria:
Pregnancy
Antibiotic use in the past month
Consumption of any product and supplement that contains probiotics during the last three months
Consumption of omega-3 and other antioxidants during the last month
Systemic glucocorticoid use during the last month
breastfeeding
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random block method will be used to allocate the samples to two groups. Blocks will be considered as 4 blocks and in each block of 4 people, two people in the intervention group and two people in the control group will be selected. The selection of the order type in each group for each person will be done through second version of random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double_ blind. Outcome elevator and participant are blinded (double blind) and aware from grouping (intervention or placebo). Patients will receive either a product containing probiotics or a placebo in identically colored and sized packages. Each package will be assigned a code corresponding to the randomized blocks. Within each block of four individuals, participants will be assigned either the placebo or the active medication. If a severe adverse reaction to the medication occurs, a designated personnel will unblind the relevant patient's code and appropriate treatment measures will be promptly initiated
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Mazandaran University of Medical Sciences
Street address
Ibn Sina hospital, Pasdaran Blvd, Sari town
City
Sari
Province
Mazandaran
Postal code
4816864193
Approval date
2024-04-17, 1403/01/29
Ethics committee reference number
IR.MAZUMS.REC.1403.047
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
Changes in the bacteria in the digestive tract of people with MS
Timepoint
At the beginning of treatment and month 6
Method of measurement
PCR
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients are prescribed one Familact (synbiotic) capsule every night following their initial disease diagnosis for a period of six months after their main meal.
Category
Treatment - Drugs
2
Description
Control group: Patients are prescribed one placebo capsule each night following their initial disease diagnosis for a period of six months after their main meal.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina hospital
Full name of responsible person
Monireh Ghazaeian
Street address
Ibn Sina hospital, Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3334 3989
Email
ghazaeianm@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram ebrahimnejad
Street address
Vice Chancellor for Research, Mazandaran University of Medical Sciences, Joybar three-way, Sari
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd, Sari town
City
Sari
Province
Mazandaran
Postal code
4816864193
Phone
+98 11 3334 3989
Email
Ghazaeianm@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd, Sari town
City
Sari
Province
Mazandaran
Postal code
4816864193
Phone
+98 11 3334 3989
Email
Ghazaeianm@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3334 3989
Email
ghazaeianm@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data related to the initial outcomes of the study will be shared
When the data will become available and for how long
The data will be available one year after publication
To whom data/document is available
Academic researchers, medical team and scientific institutes
Under which criteria data/document could be used
Requests for sharing data should be sent to the person responsible for general inquiries
From where data/document is obtainable
Requests for sharing data should be sent to the person responsible for general inquiries. ghazaeianm@gmail.com
What processes are involved for a request to access data/document
Principal investigator of the study will reply to the request within 10 days