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IRCT20180618040127N2 IRCT 2019-01-06 Mashhad University of Medical Sciences Evaluating the effect of probiotics in patients with myelopathy Evaluating the effect of probiotics on clinical signs, inflammatory and viral factors in patients with myelopathy secondary to HTLV-1 2019-02-20 anticipated 40 Complete https://irct.ir/trial/32498 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked randomization will be performed on an individual level. Foursome blocks of intervention and control groups are formed and among the 6 possible cases, 10-time selection with be performed with replacement. The generated random sequence will be placed in sealed envelopes and it will be emphasized to the researcher that they should not be rearranged, Blinding description: blinding the participants with placebo, blinding the outcome assessors, blindings the data analyser. 3 HAM/TSP patients. Intervention 1: Intervention group: Daily administration of two 500-mg capsules of Lacto-Care for 3 months. The Lacto-Capsule is an oral capsule containing the highest levels of beneficial bacteria (lactobacilli, bifidobacteria and streptococcus), along with fructooligosaccharide (contributing to the growth and activity of probiotics). The count is higher than one billion CFU and the strains and peri-biotype includes: actobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, Streptococcus thermophiles + Fructooligosaccharides (FOS). Intervention 2: Control group: ِDaily administration of two placebo (capsule in same color and shape with intervention group) for 3 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr. Fariba Zemorshidi
Before Shariati Square, Ahmadabad Street, Qaem Hospital
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3840 0000 zemorshidif@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Fariba Zemorshidi
Before Shariati Square, Ahmadabad Street, Qaem Hospital
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3840 0000 zemorshidif@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) positive serology for HTLV-1 Occurrence of spastic paraparesia Existence of anti HTLV-1 antibody in cerebrospinal fluid Rule out of other etiologies of spastic paraparesia MDG less than 9 Disease duration of less than 15 years Informed consent for participating in the study no limit no limit Both Existence of other comorbidities Receiving other drug which influence immune system B97.33 Human T-cell lymphotrophic virus, type I [HTLV-I] as the cause of diseases classified elsewhere Treatment - Drugs Placebo Intervention group: Daily administration of two 500-mg capsules of Lacto-Care for 3 months. The Lacto-Capsule is an oral capsule containing the highest levels of beneficial bacteria (lactobacilli, bifidobacteria and streptococcus), along with fructooligosaccharide (contributing to the growth and activity of probiotics). The count is higher than one billion CFU and the strains and peri-biotype includes: actobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, Streptococcus thermophiles + Fructooligosaccharides (FOS) Control group: ِDaily administration of two placebo (capsule in same color and shape with intervention group) for 3 months Medical Research Council (MRC) Scale for Muscle Strength. Timepoint: At the begging of study and 12 weeks later. Method of measurement: Physical examination. Spasticity score with Ashworth scale. Timepoint: At the begging of study and 12 weeks later. Method of measurement: Physical examination. Motor Disability score with Osame Motor Disability Score. Timepoint: At the begging of study and 12 weeks later. Method of measurement: Physical examination. Urinary disturbance score. Timepoint: At the begging of study and 12 weeks later. Method of measurement: Physical examination and medical history. Serum level of inflammatory cytokines (IL-1, IL-4, IL-6 and IFN-γ). Timepoint: At the begging of study and 12 weeks later. Method of measurement: Serum level evaluation. Mashhad University of Medical Sciences Approved 2018-11-04 Ethics committee of َMashhad University of Medical Sciences Opposite Daneshgah 18, Daneshgah Avenue, Central bulding of Mashhad University of Medical Sciences (Ghoreishi) Mashhad Razavi Khorasan Iran (Islamic Republic of)