| Revision date | Field name | Previous value |
|---|---|---|
| September 28, 2017 | summary | Objective: The aim of this study is to determine the effects of probiotic supplementation on insulin resistance, inflammatory factors and biomarkers of oxidative stress in patients with multiple sclerosis. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with multiple sclerosis, higher than 2 years of their disease and aged 20 to 60 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 48 patients with multiple sclerosis of eligible and referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either probiotic supplements (intervention group: n=24) and placebo (control group: n=24). Fasting blood samples will be taken at baseline and after 12-wk intervention. Start and end date of intervention: 3 months. Outcomes: insulin resistance, inflammatory factors and biomarkers of oxidative stress will be measured at study baseline and end-of-trial. |
| September 17, 2017 | Intervention/Control 2 | Control group: Placebo capsule, daily, for 12 weeks orally. |
| September 16, 2017 | Primary outcome time point 1 | At the beginning of the study and after 12 weeks of intervention |
| September 16, 2017 | Intervention/Control 1 | Intervention group: Probiotic capsule containing four strains of Bifidobacterium infantis (2×109 CFU/g), Lactobacillus reuteri (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g), lactobacillus plantarum (2×109 CFU/g), lactobacillus fermentum (2×109 CFU/g), and bifidobacterium lactis (2×109 CFU/g), daily, for 12 weeks orally. |