Evaluating the effect of probiotics in patients with myelopathy

Phase 3

• Conditions: HAM/TSP patients.; Human T-cell lymphotrophic virus, type I [HTLV-I] as the cause of diseases classified elsewhere; B97.33

• Registration Number: IRCT20180618040127N2
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 January 2019

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

Existence of other comorbidities
Receiving other drug which influence immune system

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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-?). Timepoint: At the begging of study and 12 weeks later. Method of measurement: Serum level evaluation.