Multiple Sclerosis. Multiple sclerosis
Conditions
Interventions
Intervention 1: Intervention group: administration of synbiotic supplement (one capsule contains Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus bulgaricus, Bifi
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: Progressive MS Patients based on EDSS criteria (RRMS, PPMS, PRMS), who agree to participate in the study. Aged between 20-60 years old Having basic literacy Mental acceptance for participation and compliance
Exclusion criteria
Exclusion criteria: Non-compliance with diet and supplement (adherence rate below 80 %) participation in other clinical trials at one time The occurrence of acute & serious medical conditions (urgent surgeries, accidents) COVID-19 infection (during the study) Taking immunomodulatory drugs - commons in relapsing-remitting MS- during and 6 months before the intervention (such as interferons, Sphingosine-1-phosphate receptor modulators, monoclonal antibodies, dimethyl fumarate) Regular consumption of anti-anxiety and anti-depressant drugs during and six months before the intervention Taking the other forms of synbiotic, probiotic, prebiotic, and postbiotic supplements during and 6 months before the intervention Taking antibiotics during and 2 months before the intervention Taking corticosteroids (for example methylprednisolone in doses more than 30 mg/day) and adrenocorticotropin hormone as full doses during and 6 months before the intervention Regular smoking (at least two cigarettes per day) Patients with pancreatitis, sepsis, dialysis, chronic diarrhea, and inpatient individuals with or without central venous catheter Patients who are waiting for abdominal surgeries Patients with acute immune deficiencies such as AIDS and cancers Patients with short bowel syndrome or at risk for mesenteric ischemia Patients who are in pregnancy or breastfeeding period or those with pregnancy attempt The unwillingness to cooperate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal level of calprotectin. Timepoint: At baseline and after 16 weeks. Method of measurement: Enzyme Linked Immuno Sorbent Assay (ELISA) kits.;Disease activity. Timepoint: At baseline and after 16 weeks. Method of measurement: scoring form of Expanded Disability Status Scale (EDSS).;Fatigue severity. Timepoint: At baseline and after 16 weeks. Method of measurement: Modified Fatigue Impact Scale 21 items (MFIS) questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| The inflammatory status of diet. Timepoint: At baseline and after 16 weeks. Method of measurement: Calculation of Dietary Inflammatory Index (DII) score.;The antioxidant level of diet. Timepoint: At baseline and after 16 weeks. Method of measurement: Calculation of Oxygen Radical Absorbance Capacity (ORAC) score.;Quality of life. Timepoint: At baseline and after 16 weeks. Method of measurement: Multiple Sclerosis Quality of Life (MSQOL-54) 54 items.;Pain severity. Timepoint: At baseline and after 16 weeks. Method of measurement: Global Pain Scale (GPS).;Sexual satisfaction level. Timepoint: At baseline and after 16 weeks. Method of measurement: Sexual Satisfaction Scale (SSS).;Bladder control evaluation. Timepoint: At baseline and after 16 weeks. Method of measurement: Bladder Control Scale (BLCS) 4 items.;Bowl control evaluation. Timepoint: At baseline and after 16 weeks. Method of measurement: Bowel Control Scale (BWCS) 5 items.;Impact of Vision Impairment evaluation. Timepoint: At baseline and after 16 weeks. Method of measurement: Impact of Vision Impairment (IVI) 32 items.;Cognitive impairment/depression evaluation. Timepoint: At baseline and after 16 weeks. Method of measurement: Perceived Deficits Questionnaire-Depression (PDQ-D) 20 items.;Anxiety severity. Timepoint: At baseline and after 16 weeks. Method of measurement: State-Trait Anxiety Inventory (STAI 1 and 2) 20 items.;Gastrointestinal evaluation. Timepoint: At baseline and after 16 weeks. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS) 15 items.;Body weight. Timepoint: At baseline and after 16 weeks. Method of measurement: SECA digital scale.;Body mass index. Timepoint: At baseline and after 16 weeks. Method of measurement: weight (in kilograms) divided by the square of height (in metres).;Percent of body fat. Timepoint: At baseline and after 16 weeks. Method of measurement: Deurenberg equation.;Waist circumference. Timepoint: At baseline and after 16 weeks. Method of measurement: | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmir Reza Moravejolahkami
Esfahan University of Medical Sciences
Outcome results
None listed