Protocol summary

Study aim
The present study aims to investigate the role of probiotics as one of the treatments for preventing allergic rhinitis and asthma, along with routine therapies, in order to reduce the burden of diseases.
Design
In this double-blinded randomized clinical trial, 30 patients will be studied through 2 groups of 15 participants. The intervention group will be under the treatment of Familact probiotic (Zist Takhmir, Iran) together with the previous common medication. The control group will receive only previous routine medications.
Settings and conduct
The study is conducted at Tabriz Imam Reza Hospital. According to the checklist, the study variables of the patients before treatment and after treatment will be analyzed. Patients randomly entering into two groups, probiotic and placebo are delivered to people for eight weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All people over the age of 15, including the male and the female, who have allergic rhinitis. All people over the age of 15, including male and females, who have asthma. Non inclusion criteria: Using antibiotics in the past 4 weeks; Food allergy; Lactose intolerance; suffering from chronic diseases; Use of corticosteroids; Suffering from underlying diseases other than asthma; Suffering from other kinds of rhinitis and respiratory diseases
Intervention groups
Intervention group: Individuals with allergic rhinitis and asthma who receive a probiotic supplement for 8 weeks in addition to their previous routine treatment. Control group: People with allergic rhinitis and asthma who receive a placebo for 8 weeks in addition to previous routine therapy.
Main outcome variables
Cough, post nasal drip, nasal discharge, nasal polyps, sleep disturbances, dyspnea, snoring, turbinates hypertrophy and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161215031429N3
Registration date: 2018-10-02, 1397/07/10
Registration timing: prospective

Last update: 2018-10-02, 1397/07/10
Update count: 0
Registration date
2018-10-02, 1397/07/10
Registrant information
Name
Yalda Jabbarimoghadam
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 161 3913
Email address
jabbariy@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Approved funds of Tabriz University of Medical Sciences
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of probiotic on clinical findings in patients with allergic rhinitis and asthma
Public title
The effect of probiotics on allergic rhinitis and asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All people over the age of 15, including the girl and the boy, who have allergic rhinitis. All people over the age of 15, including boys and girls, who have asthma.
Exclusion criteria:
Using antibiotics in the past 4 weeks Food allergy Lactose intolerance suffering from chronic diseases Use of corticostroids Suffering from underlying diseases other than asthma Suffering from other kinds of rhinitis and respiratory diseases
Age
From 15 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
After the primary visit, the participants who meet the inclusion criteria will be allocated by randomization software into two groups. The random allocation will be done through blocks of size 8 in order to make balance in number between male and female.
Blinding (investigator's opinion)
Double blinded
Blinding description
After signing informed consent by all participants, the participants will be numbered by a tertiary investigator and the numbers will be entered to the randomization software. After allocating the participants to the two groups by randomization software, the case and control groups will be determined. Then the supplements and placebo will be given to the secondary investigator, who is blind to the sequence of entering to the study. Finally, the supplements and placebo will be given to the patients of each group which is determined by the tertiary investigator who is not aware of the content of the capsules.
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
Golghast Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166857513
Approval date
2017-08-31, 1396/06/09
Ethics committee reference number
IR.TBZMED.REC.1396.461

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45.0
ICD-10 code description
Predominantly allergic asthma

2

Description of health condition studied
Allergic Rhinitis
ICD-10 code
J30
ICD-10 code description
Vasomotor and allergic rhinitis

Primary outcomes

1

Description
Cough
Timepoint
Before intervention and 4 and 8 weeks after intervention
Method of measurement
Standard Questionnaire

2

Description
Post Nasal Drip
Timepoint
Before intervention and 4 and 8 weeks after intervention
Method of measurement
Physical Examination

3

Description
Nasal Discharge
Timepoint
Before intervention and 4 and 8 weeks after intervention
Method of measurement
Physical Examination

4

Description
Nasal polyps
Timepoint
Before intervention and 4 and 8 weeks after intervention
Method of measurement
Physical Examination

5

Description
Night snoring
Timepoint
Before intervention and 4 and 8 weeks after intervention
Method of measurement
Standard questionnaire

6

Description
Sleep disturbances
Timepoint
Before intervention and 4 and 8 weeks after intervention
Method of measurement
Standard questionnaire

7

Description
Turbinates hypertrophy
Timepoint
Before intervention and 4 and 8 weeks after intervention
Method of measurement
Physical Examination

8

Description
Quality of life
Timepoint
Before intervention and 4 and 8 weeks after intervention
Method of measurement
SF-36 quality of life questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Familact probiotic capsules produced by Zist Takhmir Co. (Tehran, Iran) will be administered to patients with asthma and allergic rhinitis for 8 weeks, along with routine therapeutic treatment.
Category
Treatment - Drugs

2

Description
Control group: Placebo capsules produced by Zist Takhmir Co. (Tehran, Iran) will be administered to patients with asthma and allergic rhinitis for 8 weeks, along with routine therapeutic treatment.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Hassan Rezapour
Street address
Golghast Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
14766 51666
Phone
+98 41 3334 7056
Email
emamrezahosp@Gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Rezapour
Street address
No. 324, 2th Eastern Rose Alley, Rose St., Villashahr 2
City
Tabriz
Province
East Azarbaijan
Postal code
14766- 51666
Phone
+98 41 3335 5921
Fax
+98 41 3335 9680
Email
info@medfac.tbzmed.ac.ir
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
Hassan Rezapor
Position
ENT Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No. 324, 2th Eastern Rose Alley, Rose St., Villashahr 2
City
Tabriz
Province
East Azarbaijan
Postal code
5166857513
Phone
+98 41 3333 9589
Fax
Email
prezapour78@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Yalda Jabari Moghaddam
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Gulgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5165687386
Phone
+98 41 3382 1737
Fax
Email
yj_moghaddam@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan rezapour
Position
ENT Assistant
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No. 324, 2th Eastern Rose Alley, Rose St., Villashahr 2
City
Tabriz
Province
East Azarbaijan
Postal code
5166857513
Phone
+98 41 3382 1737
Fax
Email
prezapour78@yahoo.com
Web page address

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
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only a portion of the data, such as its original information, can be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will only be available to researchers working in academic and scientific institutions .
Under which criteria data/document could be used
All academic and researcher / all statistical analyzes are unhelpful . Use of data with the permission of the researcher and the maintenance of relevant rights .
From where data/document is obtainable
Visit the Vice-Chancellor of Research and Technology of Tabriz University of Medical Sciences or contact the researcher . Phone number: 989143821138+ or home phone: 00984133339589
What processes are involved for a request to access data/document
Access to the data is possible after two weeks after submitting to the relevant units and requesting a maximum of two weeks
Comments
Loading...