Multiple Sclerosis. Multiple sclerosis
Conditions
Interventions
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 con
Sponsors
Ahvaz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 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
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 |
|---|---|
| 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.;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDordana Hossein
Ahvaz University of Medical Sciences
Outcome results
None listed