Evaluating the effectiveness of adding probiotic to standard treatment in children with mild to moderate asthma for the improvement of asthma symptoms
Design
The clinical trial with two groups (intervention and control), pragmatic, double-blind, randomized
Settings and conduct
The aim of this study was to investigate the effect of probiotic on child's asthma in specialty and postgraduate specialty clinic of Heshamateyeh Hospital in Sabzevar city. In this study, participants and those who evaluated the outcome in children were unaware of how children were grouped. Children are randomly assigned to the intervention group ( probiotics capsule) and the control ( placebo capsules). The response to treatment is evaluated using the PRAM questionnaire at the end of The 30th day after starting intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All of 3 to 8 years old children with mild to moderate asthma
Exclusion criteria: Children Under 3 and over 8 years, Children with severe asthma, Children with seasonal allergies.
Intervention groups
Intervention group: The consumption of the probiotic 500mg capsule (made in Zist Takhmir Co.) after three meals for one month
Control group: The consumption of placebo capsule (Made in Iran Drug Laboratories) after three meals for one month
Main outcome variables
Control of asthma symptoms, Disruptions to go to the school due to a severe cough, The frequency of asthma attacks, Use nasal spray or nebulizer, The frequency of waking up at night, Control of cough symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180115038378N1
Registration date:2018-09-12, 1397/06/21
Registration timing:retrospective
Last update:2018-09-12, 1397/06/21
Update count:0
Registration date
2018-09-12, 1397/06/21
Registrant information
Name
elahe razmara
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3764 2423
Email address
ekramimilad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-15, 1397/03/25
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effect of adding probiotic oral powder to standard treatment for the improvement of mild to moderate asthma in children
Public title
Effect of probiotic supplements on children's asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All 3 to 8 years old children with mild to moderate asthma
Exclusion criteria:
Age under 3 and over 8
People with seasonal allergies
Children with severe and persistent asthma
Age
From 3 years old to 8 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization based on permutation. Accordingly, 30 blocks were allocated to patients, in each block 2 from A treatment group and 2 from the B treatment group were placed. Eventually, after completion of the blocks, group A was treated with probiotic capsule and Group B treated with placebo capsule.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each person in the study will be assigned code A and B, that the researcher will only be known of the type of groups. The outcome evaluator and practitioner is unaware of the groups. It should be noted that Probiotic and placebo are similar in appearance, color and packaging.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2018-03-14, 1396/12/23
Ethics committee reference number
IR.MEDSAB.REC.1396.179
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Control of asthma symptoms
Timepoint
The 30th day after starting intervention
Method of measurement
PRAM standard questionnaire
Secondary outcomes
1
Description
Disruption to go to the school due to a severe cough.
Timepoint
The 30th day after starting intervention
Method of measurement
PRAM standard questionnaire
2
Description
The frequency of asthma attacks
Timepoint
The 30th day after starting intervention
Method of measurement
PRAM standard questionnaire
3
Description
Use Nasal spray or Nebulizer
Timepoint
The 30th day after starting intervention
Method of measurement
PRAM standard questionnaire
4
Description
The frequency of waking up at night
Timepoint
The 30th day after starting intervention
Method of measurement
PRAM standard questionnaire
5
Description
Control of cough symptoms
Timepoint
The 30th day after starting intervention
Method of measurement
PRAM standard questionnaire
Intervention groups
1
Description
Intervention group: Patients in this group consume 500 mg of Fmilact probiotics (produced by Zist Takhmir Company) for one month after three meals.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group consume placebo capsules (prepared in the Iranian Pharmacy Lab) for one month after three meals.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmatiyeh hospital
Full name of responsible person
Elahe Razmara Farzaghi
Street address
Heshamatiyeh Hospital, Asadabady Ave., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1014
Email
razmarae@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshte Ghorat
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
Email
Drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Dr Homan Tehrani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1604
Email
tehranih911@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr Homan Tehrani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Practitioner
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9671965751
Phone
+98 51 4401 1604
Email
tehranih911@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Elahe Razmara Farzaghi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 3601 7253
Email
ekramimilad@yahoo.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
Not applicable
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available