Investigating the effects of probiotic supplementation on the functional ability of multiple sclerosis patients
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 90 patients
Settings and conduct
In this study, the examiner and the patients will not know the type of received intervention. Patients will be provided with tablets of the same shape in sealed envelopes, and a code (from 1 to 90) will be defined for each of them. Patients will receive one of the interventions randomly. The location of the study will be the Neurology Clinic of Imam Reza Medical Education Center, affiliated to Tabriz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Definitive diagnosis of multiple sclerosis based on the MacDonald criteria of the 2017 version; RRMS disease type
Intervention groups
Patients will be divided into 2 groups: probiotic supplement and placebo.
Intervention group: LactoCare probiotic supplement that contains high amounts of 12 beneficial and safe bacterial strains along with fructooligosaccharides as prebiotics. Patients will take this supplement once daily and oral for 4 months.
ontrol group: placebo. This capsule contains an ineffective substance (starch powder) that patients will take once daily for 4 months.
Main outcome variables
The measure of physical disability of patients based on the EDSS scale; Gait status of patients; hand function; cognitive findings; fatigue; Psychiatric disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220713055465N1
Registration date:2022-08-30, 1401/06/08
Registration timing:registered_while_recruiting
Last update:2022-08-30, 1401/06/08
Update count:0
Registration date
2022-08-30, 1401/06/08
Registrant information
Name
Amirreza Naseri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7310
Email address
amirx2eza@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of probiotics in functional abilities of multiple sclerosis patients: a randomized double-blind placebo-control trial
Public title
Probiotic supplementation in multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of multiple sclerosis based on 2017 MacDonald criteria
RRMS
Informed consent
Exclusion criteria:
Lack of consent to continue the study at any stage
The presence of other neurological diseases at the same time as MS
Diabetes mellitus (DM)
Anemia
Other inflammatory diseases
Rheumatological diseases
Acute and chronic infectious diseases (including urinary tract infection)
Discopathy
Relapsing of the disease in the last 4 months
Receiving pulse coronet during the last 4 months
Progressive MS
CIS (Clinically isolated syndrome)
Literacy level below 12 years and lack of proficiency in Persian language
Severe depression and use of antidepressants
Alcohol or drug abuse
Thyroid disorders
Taking drugs that affect fatigue
Pregnancy
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers
In this method, each person participating in the study is assigned a number (from 1 to 90; according to the sample size) and a subset of the population is randomly selected using a table of random numbers. Even numbers are assigned to the intervention group and odd numbers to the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The examiner, the patient, and the data analyst will not know the type of intervention the patient received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Approval date
2022-08-01, 1401/05/10
Ethics committee reference number
IR.TBZMED.REC.1401.426
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Cognitive Impairment
Timepoint
Baseline and end of treatment period
Method of measurement
Symbol Digit Modalities Test and Paced Auditory Serial Addition Test
2
Description
Depression
Timepoint
Baseline and end of treatment period
Method of measurement
Beck's Depression Inventory
3
Description
Physical disabilities
Timepoint
Baseline and end of treatment period
Method of measurement
Expanded Disability Status Scale (EDSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: LactoCare probiotic supplement that contains high amounts of 12 beneficial and safe bacterial strains along with fructooligosaccharides as prebiotics. Patients will take this supplement once daily and oral for 4 months.
Category
Treatment - Drugs
2
Description
Control group: placebo. This capsule contains an ineffective substance (starch powder) that patients will take once daily for 4 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Tabriz
Full name of responsible person
Mahnaz Talebi
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 0730
Fax
+98 41 3334 0730
Email
Talebi511@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Talebi
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 0730
Fax
+98 41 3334 0730
Email
Talebi511@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Talebi
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 0730
Fax
+98 41 3334 0730
Email
Talebi511@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Talebi
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 0730
Fax
+98 41 3334 0730
Email
Talebi511@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amirreza Naseri
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7310
Fax
Email
amirx2eza@gmail.com
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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcomes will be reported.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data will be available for use in other studies such as review studies.
From where data/document is obtainable
Mahnaz Talebi
Email: Talebi511@yahoo.com
Neurosciences Research Center (NSRC), Tabriz University of Medical Sciences, Tabriz, Iran
What processes are involved for a request to access data/document
Email to correspondence
Mahnaz Talebi
Email: Talebi511@yahoo.com
Neurosciences Research Center (NSRC), Tabriz University of Medical Sciences, Tabriz, Iran