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IRCT20181210041918N2 IRCT 2020-08-21 Ahvaz University of Medical Sciences Effect of probiotic in patients with Multiple Sclerosis ‍‍ Survey the effect of probiotic supplementation on the intestinal metabolites, some oxidative stress indicators, fatigue, pain and depression in patients with Multiple Sclerosis 2019-01-04 anticipated 50 Complete https://irct.ir/trial/50321 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who are eligible for the study are randomly assigned to one of the two groups receiving probiotic supplementation and placebo supplementation. Thus, supplements and placebo from both groups are randomly coded by an individual other than the researcher from No. 1-50 and according to the entry of patients to study, a code is assigned to them. Then The patients are randomly divided into 2 groups of 25 with balanced block method as follows: 1- Group A (probiotic): Daily intake of two capsules 2. Group B (placebo): Placebo, similar to the high sachet made from corn starch (prepared by the company Protexin) Block randomization method has been used for randomization. Blocks size of 4 are generated using www.sealedenvelope.com, Blinding description: None of the patients, as well as the researcher, clinical care, the outcome evaluator and data analyzer will be aware of the group in which the patients are located and the type of intervention received. In order to conceal the randomization process, individual codes have been on the medicine boxes, which are produced by the software. 3 Multiple Sclerosis. Intervention 1: Intervention group: Supplements used in this study include probiotic capsules prepared by the company Protexin (UK) or placebo (starch). Each probiotic capsule containing probiotic contains 109 * 2 * CFU / g of each species of Lactobacillus acidophilus, Lactobacillus casei , Bifidobacterium bifidum and Lactobacillus fermentum, Lactobacillus bulgaricus and Streptococcus thermophilus. Intervention 2: Control group: Control group:Placebo in similar packages with probiotic supplementation from corn starch (prepared by the company Protexin). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is it is not the objective of this study.
public Dordana Hossein
Faculty of Paramedicine, Jundishapur University of Medical Sciences
Ahwaz Iran (Islamic Republic of) 6135715794 +98 61 3581 5751 rahimlum@gmail.com Ahvaz University of Medical Sciences scientific Dr. Dordaneh Hossein
Paramedical School, Ahvaz Jundishapur University of Medical Sceinces, Golestan Blvd., Ahvaz
Ahwaz Iran (Islamic Republic of) 61357-15794 +98 61333367570 hossein_D@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Selection based on revised Mc Donald criteria a relapsing–remitting course one or more documented relapses in the previous year or two or more in the previous 2 years a score of 0 to 5.5 on the EDSS Age range between 18 to 55 18 years 55 years Both Unwillingness to continue cooperation Exacerbation of the disease during the study There is a relapse during the intervention History of antibiotic use during 1 month ago Consumption of any probiotic and prebiotic supplement and antibiotic in the last 1 month Consumption supplements containing of vitamin, fiber, omega-3, anti-oxidants during 3 weeks before and during the study. Taking non-steroidal anti-inflammatory drugs (NSAIDs), estrogen, progesterone, immunosuppressions, diuretics and corticosteroids drugs. History of gastroenteritis during the last month History of intestinal surgery during the past month Inflammatory bowel disease (IBD), rheumatoid arthritis, systemic lupus, type 1 diabetes and other autoimmune diseases and pregnancy G35 Multiple sclerosis Treatment - Drugs Placebo Intervention group: Supplements used in this study include probiotic capsules prepared by the company Protexin (UK) or placebo (starch). Each probiotic capsule containing probiotic contains 109 * 2 * CFU / g of each species of Lactobacillus acidophilus, Lactobacillus casei , Bifidobacterium bifidum and Lactobacillus fermentum, Lactobacillus bulgaricus and Streptococcus thermophilus. Control group: Control group:Placebo in similar packages with probiotic supplementation from corn starch (prepared by the company Protexin) Antioxidant index levels (malondialdehyde and total antioxidant capacity). Timepoint: Before the intervention and after the end of the 12-week intervention period. Method of measurement: Serum samples will be stored for measuring antioxidant index values up to 80 ° C in the freezer. Measuring serum levels of malondialdehyde and total antioxidant capacity using ELISA kit produced by Zellbio Germany will be carried out in accordance with the instructions contained in the kits of the Guideline. Fatigue Assessment. Timepoint: Before the intervention and after the end of the 12-week intervention period. Method of measurement: Fatigue inventory (MFI-20) will be used at the beginning and end of the study to assess fatigue in patients. The questionnaire has three sub-sections, including physical, cognitive and psychological evaluation of fatigue, and ultimately gives a score of 0 to 84 for fatigue. The above is a sign of high fatigue severity. Changes in pain intensity. Timepoint: Before the intervention and after the end of the 12-week intervention period. Method of measurement: Pain intensity (NRS) was assessed with a numerical rating scale (scaled from 0 to 10) addressing the average pain, which is associated with MS according to the patient’s point of view. Thereby, 0 represents no pain and 10 the most painful sensation imaginable. Quality of pain (SES) was measured by the pain sensation scale. This tool contains 24 adjectives of pain sensation in a questionnaire; each of them is scaled from 1 to 4. Fourteen items comprise the affective dimension, and ten items contribute to the sensory dimension. Severity of depression. Timepoint: Before the intervention and after the end of the 12-week intervention period. Method of measurement: The Beck Depression Inventory-II (BDI-II) questionnaire included 21 questions to assess depression in patients. Each questionnaire takes a score from 0 to 3. The high score indicates high symptoms of depression. Fecal chloroform. Timepoint: In the first three days of the study and the last 3 days of study. Method of measurement: Stool samples from each patient were taken in the first 3 days of the study, as well as the last 3 days of study in the sterile plastic container, and the transfer to sterile tubes will be maintained to evaluate the changes in the gastrointestinal flora within the 80-oz. By using bacterial culture, the number of colonies associated with lactobacillus, bifidobacter and chloroform is measured. Ahvaz University of Medical Sciences Approved 2020-02-08 Ethics committee of Ahwaz Jundishapur University of Medical Sciences Golestan Highway Ahwaz Khouzestan Iran (Islamic Republic of)