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IRCT20141108019853N7 IRCT 2021-08-15 Esfahan University of Medical Sciences Effect of synbiotic and anti-inflammatory-antioxidant rich diet in progressive multiple sclerosis Effect of synbiotics supplementation and anti-inflammatory-antioxidant rich diet on inflammatory marker and clinical manifestations in patients with progressive forms of Multiple Sclerosis 2021-08-13 anticipated 70 Complete https://irct.ir/trial/55617 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The current study is a co-intervention of Diet & Nutritional Supplement, Randomization description: Randomization will be conducted based on https://www.sealedenvelope.com/simple-randomiser/v1/lists. Each block has a capacity for 6 subjects. Then, within each block, subjects will be randomly assigned to treatment or placebo. Random assignment will be done using a random chain that will be extracted from the site. Randomization will be stratified based on the type of progressive MS (three types: PPMS, SPMS, PRMS), Blinding description: Synbiotic supplements and placebo (identical in color, shape, and odor) will be packaged in similar boxes and the researcher and patients will not be informed of the contents of the packs until the end of the study. In addition, the individualized diets and dietary recommendations will be packaged in similar packets. Furthermore, the outcome assessor and data analyzer will be blinded to treatment allocation. HOWEVER, blinding of the investigator is not possible because of obvious differences between the intervention diet (in the intervention group) and dietary recommendations (in the control group). 3 Multiple Sclerosis. Intervention 1: Intervention group: administration of synbiotic supplement (one capsule contains Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, Streptococcus thermophilus) in dose of 4.5* 10^11 per day and FOS 100 mg/day plus anti-inflammatory-antioxidant rich diet for 4 months (16 weeks). Intervention 2: Control group: one placebo capsule per day (contains starch) plus dietary recommendations and energy adjustment for 4 months (16 weeks). Yes - There is a plan to make this available What will be shared: The major part of results will be available for individuals. Moreover, the datasets used and/or analyzed during the current study are available from the investigators, on reasonable request. When: The data will become available 12 months after the results' publication. To whom: The data/document is available for all individuals, on reasonable request. Conditions: The data/document must be used for conducting similar studies and therapeutic approaches, on reasonable request from the investigators. Where to obtain: mail to paknahad@hlth.mui.ac.ir or a.moravej@mail.mui.ac.ir How to obtain: The data will be sent as soon as possible, after receiving the request. Comments:
public Amir Reza Moravejolahkami
Hezar Jerib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3335 4453 amimohs@gmail.com Esfahan University of Medical Sciences scientific Zamzam Paknahad
Hezar Jerib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3166 paknahad@hlth.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 20 years 60 years Both 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 G35 Multiple sclerosis Treatment - Other Placebo Intervention group: administration of synbiotic supplement (one capsule contains Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, Streptococcus thermophilus) in dose of 4.5* 10^11 per day and FOS 100 mg/day plus anti-inflammatory-antioxidant rich diet for 4 months (16 weeks) Control group: one placebo capsule per day (contains starch) plus dietary recommendations and energy adjustment for 4 months (16 weeks) 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. 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: tape. Hip circumference. Timepoint: At baseline and after 16 weeks. Method of measurement: tape. Waist-to-hip ratio. Timepoint: At baseline and after 16 weeks. Method of measurement: ratio calculation. Triceps Skinfold thickness. Timepoint: At baseline and after 16 weeks. Method of measurement: Skinfold Caliper. Mid-Arm Circumference (MAC). Timepoint: At baseline and after 16 weeks. Method of measurement: tape. Corrected mid-Arm Muscle Area (cAMA). Timepoint: At baseline and after 16 weeks. Method of measurement: cAMA equation. Physical activity. Timepoint: At baseline and after 16 weeks. Method of measurement: three-day record. Esfahan University of Medical Sciences Approved 2021-07-26 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib Ave. Isfahan Isfehan Iran (Islamic Republic of)