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IRCT20190804044429N12 IRCT 2024-07-06 Mazandaran University of Medical Sciences The effects of synbiotic product on gut microbiota changes in patients with multiple sclerosis treated with dimethyl fumarate 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 2024-06-21 anticipated 60 Complete https://irct.ir/trial/76575 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Multiple sclerosis. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Data related to the initial outcomes of the study will be shared When: The data will be available one year after publication To whom: Academic researchers, medical team and scientific institutes Conditions: Requests for sharing data should be sent to the person responsible for general inquiries Where to obtain: Requests for sharing data should be sent to the person responsible for general inquiries. ghazaeianm@gmail.com How to obtain: Principal investigator of the study will reply to the request within 10 days Comments:
public Monireh Ghazaeian
Ibn Sina hospital, Pasdaran Blvd, Sari town
Sari Iran (Islamic Republic of) 4816864193 +98 11 3334 3989 Ghazaeianm@gmail.com Mazandaran University of Medical Sciences scientific Monireh Ghazaeian
Ibn Sina hospital, Pasdaran Blvd, Sari town
Sari Iran (Islamic Republic of) 4816864193 +98 11 3334 3989 Ghazaeianm@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 G35 Multiple sclerosis Treatment - Drugs Placebo 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. 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. 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. Mazandaran University of Medical Sciences Approved 2024-04-17 Research Ethics Committees of Mazandaran University of Medical Sciences Ibn Sina hospital, Pasdaran Blvd, Sari town Sari Mazandaran Iran (Islamic Republic of)