Protocol summary

Study aim
Probiotic prescribing on immune responses and clinical manifestations in patients with parennial allergic rhinitis
Design
Pragmatic, community based, parallel group, double blind, randomised controlled trial
Settings and conduct
Before and 6 months after the intervention, Brachial vein of 5cc patients is taken to perform flow cytometric studies and serum preparation for the sample bank. Also, the miniRQLQ and SNOT22 questionnaires, which are related to quality of life and severity of the disease, are completed before and after the intervention by the patients.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: All patients with parennial allergic rhinitis aged 5 to 5 years old living in Mashhad and surrounding cities who have positive skin tests with aeroallergen and who are required to collaborate. exclusion criteria: Patients with a history of autoimmune disease, patients who have systemic corticosteroids or immunosuppressive drugs that are effective on the immune system, pregnant women, immunocompromised patients, patients with allergic asthma,Malnutrition patients, and patients Antibiotics are used for any reason during the use of the probiotic.
Intervention groups
Patients are divided into two equal groups (in each group of 15) using a randomized block method. In addition to common allergic rhinitis treatments, lactocare is prescribed and in the other group, in addition to the usual treatments, placebo is prescribed.
Main outcome variables
The level of IL25 proteins affects the frequency of Th1, Th2, Th17, and Treg cells, as well as the expression of T-bet, GATA3, RORgamma t and FOXP3 transcription factor gene expression at the start of the process, six months after the course.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150716023235N14
Registration date: 2019-01-14, 1397/10/24
Registration timing: prospective

Last update: 2019-01-14, 1397/10/24
Update count: 0
Registration date
2019-01-14, 1397/10/24
Registrant information
Name
Farahzad Jabbari Azad
Name of organization / entity
Allergy Research Center, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2770
Email address
jabbarif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-09, 1397/11/20
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of Probiotic lactocare effect on immune responses and clinical manifestation in patients with parennial allergic rhinitis
Public title
The evaluation of Probiotic lactocare effect on patients with parennial allergic rhinitis
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with parennial allergic rhinitis aged 5 to 5 years old. Who have positive skin tests with aeroallergen. They have to collaborate.
Exclusion criteria:
Patients with a history of autoimmune disease. patients who have systemic corticosteroids or immunosuppressive drugs that are effective on the immune system. pregnant women, immunocompromised patients, patients with allergic asthma. malnourished patients patients who have either The reason why you take antibiotics when taking Probiotic.
Age
From 5 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Method of block randomization Unit of randomization individual Tools used in randomization computer softwares
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will receive the same drug or placebo The main researcher is unaware of the effect of the drug on improving quality of life and effective immune responses.
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
Allergy Research Center, Ghaem Hospital, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2018-12-19, 1397/09/28
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.477

Health conditions studied

1

Description of health condition studied
Allergic rhinitis
ICD-10 code
J30.3
ICD-10 code description
Other allergic rhinitis

Primary outcomes

1

Description
Interleukin 25 ,Quality of life
Timepoint
Before intervention, 6 months after intervention
Method of measurement
quality of life:miniRQLQ and SNOT22 questionnaires, interleukin 25:elisa kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:In addition to the usual treatments for allergic rhinitis, Steroids nasal spray Rhinocort, a lactocare probiotic daily that contains strains: lactobacillus casei, lactobacillus acidophilus, lactobacillus rhamnosus, lactobacillus bolgaricus, bifidobacterium bereve, bifidobacterium longum, stereptococus thermophilus is prescribed.The duration of the intervention is 6 months.  probiotic lactocare from the Zist Takhmir company is Iran.
Category
Treatment - Drugs

2

Description
Control group:In addition to the usual treatments, Steroids nasal spray Rhinocort,a placebo is prescribed daily.The duration of the intervention is 6 months . The placebo from the Zist Takhmir company is Iran.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Doctor Farahzad Jabari Azad
Street address
Iran, Mashhad, Ahmadabad, Ghaem Hospital, Allergy Research Center
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 2081
Email
Arezoofaridzadeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Doctor Mohsen Tafaghodi
Street address
Ahmad Abad Boulevard, Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 2081
Email
JabbariF@mums.ac.ir
Grant name
Allergy Research Center, Bu Ali Research Center
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
Arezoo Faridzadeh
Position
Medical doctor.Phd candidate
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
Allergy Research Center, Ghayegh Hospital, Ahmedabad Boulevard, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 38049
Email
Arezoofaridzadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arezoo Faridzadeh
Position
Medical doctor.Phd candidate
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
Allergy Research Center, Ghayegh Hospital, Ahmedabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 38049
Email
arezoofaridzadeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arezoo Faridzadeh
Position
Medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
Allergy Research Center, Ghayegh Hospital, Ahmedabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 38049
Email
arezoofaridzadeh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
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