In this study, allergic rhinitis patients were divided into two groups: control and intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with chronic allergic rhinitis who have clinical symptoms consistent with allergic rhinitis and a positive skin test with aeroallergens; age above 8 years and less than 50 years old; patient satisfaction.
Exclusion criteria: Taking antibiotics while taking probiotics; consumption of compounds containing probiotics other than the medicine prescribed in the study; suspected drug allergy symptoms; the patient's non-cooperation in regular drug use and tests; pregnancy; taking immunosuppressive drugs; malnutrition; having a history of autoimmune disease or cystic fibrosis or active sinus infection; sinus pain; increased thick nasal secretions.
Intervention groups
In this clinical trial, patients with allergic rhinitis will divided into two groups:
Control group – Participants will take intranasal Mometasone twice daily for three months. In the first month, also use a placebo nasal spray twice a day.
Intervention group (Probiotic group) - In the first month, participants will use Mometasone nasal spray with probiotic nasal spray twice daily. In the second and third months, they will take only probiotic nasal spray twice daily.
Main outcome variables
Clinical symptoms; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150716023235N19
Registration date:2023-12-09, 1402/09/18
Registration timing:registered_while_recruiting
Last update:2023-12-09, 1402/09/18
Update count:0
Registration date
2023-12-09, 1402/09/18
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
2023-11-22, 1402/09/01
Expected recruitment end date
2025-11-22, 1404/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Nasal Probiotic Efficacy in Perennial Allergic Rhinitis Symptom Control and Recurrence
Public title
Nasal Probiotic Efficacy in Allergic Rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with chronic allergic rhinitis who have clinical symptoms consistent with allergic rhinitis and a positive skin test with aeroallergens
Age above 8 years and less than 50 years
Patient satisfaction
Exclusion criteria:
Taking antibiotics while taking probiotics
Consumption of compounds containing probiotics other than the medicine prescribed in the study
Suspected drug allergy symptoms
The patient's non-cooperation in regular drug use and tests
Pregnancy
Taking immunosuppressive drugs
Malnutrition
Having a history of autoimmune disease or cystic fibrosis
Active sinus infection, sinus pain, increased thick nasal secretions
Age
From 8 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the blocking method will be used. In this way, study group A and control group B will be considered. According to the sample size of two groups, 8 random blocks of 4 are used.
1. AABB BBAA
2. BBAA AABB
3. ABAB AABB
4. BABA ABAB
The random numbers table (https://www.Randomization.com) will be used to place the samples in the blocks randomly.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The sprays prepared in the intervention and control groups are completely similar in terms of shape, appearance, and smell. Allocation of people in two groups will be done randomly. The groups will be entered into SPSS software as A and B, and the analyst will not know about the intervention and control groups. In two follow-ups, one and three months, it will be done by a doctor who does not know about the division of patients into intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2023-08-14, 1402/05/23
Ethics committee reference number
IR.MUMS.IRH.REC.1402.115
Health conditions studied
1
Description of health condition studied
Allergic Rhinitis
ICD-10 code
J30.1
ICD-10 code description
Allergic rhinitis due to pollen
Primary outcomes
1
Description
Nasal smear eosinophils
Timepoint
Before intervention, after 1 and 3 months of intervention
Method of measurement
Microscopical observation
2
Description
Clinical symptoms
Timepoint
Before intervention, after 1 and 3 months of intervention
Method of measurement
SNOT22 Questionnaire
3
Description
Quality of Life
Timepoint
Before intervention, after 1 and 3 months of intervention
Method of measurement
miniRQLQ Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: (Probiotic group) - In the first month, participants will use Mometasone nasal spray with probiotic nasal spray twice daily. In the second and third months, they will take only probiotic nasal spray twice daily.
Category
Treatment - Drugs
2
Description
Control group: control group – Participants will take intranasal Mometasone twice daily for three months. In the first month, also use a placebo nasal spray twice a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Allergy clinic of Ghaem Hospital
Full name of responsible person
Rana Tafrishi
Street address
Ahmad abad AVE, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
991991766
Phone
+98 935 609 1846
Email
ranatafrishi96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farahzad Jabbari Azad
Street address
Ahmad abad AVE, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
991991766
Phone
+98 915 316 7868
Email
jabbarif@mums.ac.ir
Grant name
Mashhad University of Medical Sciences Faculty Grant
Grant code / Reference number
4012452
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
Rana Tafrishi
Position
fellowship of allergy and clinical immunology
Latest degree
Specialist
Other areas of specialty/work
Immunology
Street address
Ahmad abad AVE, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
991991766
Phone
+98 51 3801 2298
Email
ranatafrishi96@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farahzad Jabbari Azad
Position
Proffessor
Latest degree
Subspecialist
Other areas of specialty/work
Allergy and clinical imuunology
Street address
Department of Immunology and Allergy, Hospital Ghaem, Ahmadabad streets, Mashhad Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9119-91766
Phone
+98 51 3801 2298
Email
jabbarif@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Rana Tafrishi
Position
student
Latest degree
Specialist
Other areas of specialty/work
Allergy and clinical imuunology
Street address
epartment of Immunology and Allergy, Hospital Ghaem, Ahmadabad streets, Mashhad Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
991991766
Phone
+98 51 3801 2298
Email
ranatafrishi96@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not 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
Not applicable
Title and more details about the data/document
Not applicable
When the data will become available and for how long
Not applicable
To whom data/document is available
Not applicable
Under which criteria data/document could be used
Not applicable
From where data/document is obtainable
Not applicable
What processes are involved for a request to access data/document