Multiple Sclerosis. Multiple sclerosis
Conditions
Interventions
Intervention 1: 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
Sponsors
Ahvaz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Diagnosis based on Mc Donald and MRI criteria EDSS score is less than 3 Clinical status of relapse-remittance
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum level of TGF-ß. Timepoint: Before the intervention and after the end of the 12-week intervention period. Method of measurement: Serum samples will be stored for measuring TGF-ß values up to 80 ° C in the freezer. Measuring serum levels of TGF-ß using ELISA kit produced by Zellbio Germany will be carried out in accordance with the instructions contained in the kits of the Guideline.;Serum level of IL-17. Timepoint: Before the intervention and after the end of the 12-week intervention. Method of measurement: Serum samples will be stored for measuring IL-17 values up to 80 ° C in the freezer. Measuring serum levels of IL-17 using ELISA kit produced by Zellbio Germany will be carried out in accordance with the instructions contained in the kits of the Guideline.;Serum level of hs-CRP. Timepoint: Before the intervention and after the end of the 12-week intervention. Method of measurement: Serum samples will be stored for measuring hs-CRP values up to 80 ° C in the freezer. Measuring serum levels of hs-CRP using ELISA kit produced by Zellbio Germany will be carried out in accordance with the instructions contained in the kits of the Guideline.;Serum level of FOXP3. Timepoint: Before the intervention and after the end of the 12-week intervention. Method of measurement: Serum samples will be stored for measuring FOXP3 values up to 80 ° C in the freezer. Measuring serum levels of FOXP3 using ELISA kit produced by Zellbio Germany will be carried out in accordance with the instructions contained in the kits of the Guideline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of bifidobacter colonies. 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.;Number of lactobacillus colonies. 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.;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.;Changes in pain intensity. Timepoint: The beginning and the end of the study. 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehran Rahimlou
Ahvaz University of Medical Sciences
Outcome results
None listed