Evaluating the therapeutic effects of probiotics on the immunopathogenesis of patients with HTLV-1-induced myelopathy and its' effect on clinical signs and viral and inflammatory factors
Design
A phase 3, triple-blinded, controlled clinical trial with two parallel group desgin of 40 patients in a single center
Settings and conduct
The study will be performed at the Department of Neurology at Ghaem Hospital in Mashhad. Patients will be blinded with placebo and outcome assessors and data analyser will be unaware of study groups.
Participants/Inclusion and exclusion criteria
Patients with HTLV-1-induced myopathy who has passed less than 15 years of onset symptoms
Intervention groups
Intervention group: Oral administration of two 500-mg Lacto-Care capsules daily for 3 months
Control group: Oral administration placebo (same capsule regarding colour and shape compared to the intervention group) for 3 months
Main outcome variables
The measures of MRC (muscle strength); Ashworth (spasticity); OMDS (motor disability); UDS (urinary tract disorder); Serum levels of IL-1, IL-4, IL-6 and IFN-γ; viral load levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180618040127N2
Registration date:2019-01-06, 1397/10/16
Registration timing:prospective
Last update:2019-01-06, 1397/10/16
Update count:0
Registration date
2019-01-06, 1397/10/16
Registrant information
Name
Zohreh Vahidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 9828
Email address
vahidizh3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of probiotics on clinical signs, inflammatory and viral factors in patients with myelopathy secondary to HTLV-1
Public title
Evaluating the effect of probiotics in patients with myelopathy
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
Blinding description
blinding the participants with placebo, blinding the outcome assessors, blindings the data analyser
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of َMashhad University of Medical Sciences
Street address
Opposite Daneshgah 18, Daneshgah Avenue, Central bulding of Mashhad University of Medical Sciences (Ghoreishi)
City
Mashhad
Province
Razavi Khorasan
Postal code
91357-345
Approval date
2018-11-04, 1397/08/13
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.485
Health conditions studied
1
Description of health condition studied
HAM/TSP patients
ICD-10 code
B97.33
ICD-10 code description
Human T-cell lymphotrophic virus, type I [HTLV-I] as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Medical Research Council (MRC) Scale for Muscle Strength
Timepoint
At the begging of study and 12 weeks later
Method of measurement
Physical examination
2
Description
Spasticity score with Ashworth scale
Timepoint
At the begging of study and 12 weeks later
Method of measurement
Physical examination
3
Description
Motor Disability score with Osame Motor Disability Score
Timepoint
At the begging of study and 12 weeks later
Method of measurement
Physical examination
4
Description
Urinary disturbance score
Timepoint
At the begging of study and 12 weeks later
Method of measurement
Physical examination and medical history
5
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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)
Category
Treatment - Drugs
2
Description
Control group: ِDaily administration of two placebo (capsule in same color and shape with intervention group) for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem Hospital
Full name of responsible person
Dr. Fariba Zemorshidi
Street address
Ahmad abad Street, before Shariati Square. Qaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Email
zemorshidif@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Oposite Daneshgah 18 Street, Daneshgah Street, Central Bulding of Mashhad University of Medical Sciences (Ghoreishi)
City
Mashhad
Province
Razavi Khorasan
Postal code
91357-345
Phone
+98 51 3841 2081
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Fariba Zemorshidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Before Shariati Square, Ahmadabad Street, Qaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Email
zemorshidif@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Fariba Zemorshidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Before Shariati Square, Ahmadabad Street, Qaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Email
zemorshidif@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Fariba Zemorshidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Before Shariati Square, Ahmadabad Street, Qaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Email
zemorshidif@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available