Investigating the effect of preventive symbiotic administration on the incidence of allergic diseases in children aged 0 to 5 years, a clinical trial study
Investigating the effect of preventive symbiotic prescription on the incidence of allergic diseases in children 0 to 5 years old
Design
The clinical trial has a placebo group, in parallel, double-blind, randomized, in phase 2 of the study, 400 patients selected from the first phase will be conducted. Random sequence generation software will be used for randomization.
Settings and conduct
This study will be conducted in the health centers of Mashhad University of Medical Sciences. This study is double-blind. The symbiotic and placebo drops are similar in appearance, taste and smell. The symbiotic and placebo drops, which are completely similar, have been placed in sterile packages and unique codes have been assigned to each package. The patient is the delivery person. The medicine given to the patient and the filling of the questionnaires are of the type of medicine inside the package, blind
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Completing the consent form to participate in the research
2. 38 to 42 weeks term baby with a normal weight of 2500 to 3999 grams at the time of birth
3. Based on the questionnaire Module 2.5: Risk factor questionnaire, the family is at risk for allergic diseases
4. Residents of Mashhad
5. No history of immune deficiency in the family
Intervention groups
The prescription of symbiotic drops will be given in the form of one cc per day, every other month for12 months.
Placebo group: Placebo drops will be given in the form of one cc per day for a period of 12 months.
There is no control group in this study
Main outcome variables
Incidence of jaundice; infantile-colic; atopic-dermatitis; allergic rhinitis; eczema; asthma; upper respiratory infection; pneumonia and diarrhea
General information
Reason for update
Acronym
MSS (Mashhad symbiotic study)
IRCT registration information
IRCT registration number:IRCT20211211053351N2
Registration date:2023-11-25, 1402/09/04
Registration timing:prospective
Last update:2023-11-25, 1402/09/04
Update count:0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
sadeghi tahereh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 7313
Email address
sadeghit@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2028-12-21, 1407/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of preventive symbiotic administration on the incidence of allergic diseases in children aged 0 to 5 years, a clinical trial study
Public title
Preventive symbiotic administration on the incidence of allergic diseases in children aged 0 to 5 years
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Be a resident of Mashhad city
Completing the consent form to participate in the research
Term neonatal 38 to 42 weeks
Normal weight at birth is 2500 to 3999 grams
According to Module 2.5: Risk factor questionnaire, the family is at risk for allergic diseases
Exclusion criteria:
Abnormalities of the newborn in the cardiac, skeletal, nervous system
Age
From 1 day old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization methods are used and
The randomization program is repeated until the desired balance is achieved.
The sample size is 200 people in each group, in the event that after the completion of the simple randomization program, if the inequality between the groups is more than 20 people, the creation of a random sequence will be repeated and the new program will replace the previous program.
Researchers will repeat this process until receive the desired criterion. The number of samples allocated to each of the studied groups will be equal.
The size of all blocks is equal and we will have two groups of 6 blocks in this trial (including 3 participants in the intervention group and 3 participants in the control group).
The randomization tool is also used from the software for generating random sequences (random allocation software), which in addition to simple randomization, these random sequence generating software are capable of generating random sequences using the block method.
Blinding (investigator's opinion)
Double blinded
Blinding description
After selecting the samples, none of the participants will be aware of randomization and allocation to groups. Physicians will be given a table of pre-coded numbered numbers and patients will be entered into the study in order of table numbers. Therefore, the present study will be double-blind. Symbiotic drops and placebo drops manufactured by Zisttakhmir will be given to the control and intervention groups. And the placebo is the same in terms of shape, color and size and is delivered to the patient's parents in the package.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Mashhad University of Medical Sciences
Street address
Knowledge and Health City, In the end of Shahid Fakouri Blvd (In front of Fakouri ٩۴), Mashhad - Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9919191778
Approval date
2023-09-09, 1402/06/18
Ethics committee reference number
IR.MUMS.REC.1402.217
Health conditions studied
1
Description of health condition studied
Allergic diseases in children
ICD-10 code
J45.0
ICD-10 code description
Predominantly allergic asthma
Primary outcomes
1
Description
Incidence of jaundice
Timepoint
The first month
Method of measurement
The bilirubin of newborns will be recorded up to 2 weeks and the management of jaundice, which includes hospitalization, use of medicine, blood exchange and its treatment measures, will be evaluated.
2
Description
Incidence of infantile colic
Timepoint
First month, third month of birth
Method of measurement
According to Wessel's diagnostic criterion, crying of a healthy infant for 3 hours a day, for 3 days a week and in 3 consecutive weeks is infantile colic, which is measured by the infantile colic scale questionnaire (ICS). This scale includes 22 items or questions that were scored from very little (with a score of 1) to very high (with a score of 5).
3
Description
Atopic dermatitis
Timepoint
The effect of Symbiotic use on the occurrence of allergic diseases in children will be evaluated at one month, 3 months, 12 months, 24 months, and 60 months.
Method of measurement
The severity of the disease will be determined based on the SCORAD criteria, and this questionnaire will be completed by the interviewer and with the cooperation of the parents of infants or their caregivers.
4
Description
Allergic rhinitis
Timepoint
Third month, 12 months, 24 months, 60 months
Method of measurement
Diagnosis of allergic rhinitis based on history of rhinorrhea, nasal congestion and sneezing, itching, (if two or more of these symptoms are present for at least one hour on most days), along with at least one atopy criterion (family history of allergies, Elevated IgE or positive skin test is present Nose and throat examination will be used to rule out infectious rhinitis.
5
Description
ََAsthma
Timepoint
Third month, 12 months, 24 months, 60 months
Method of measurement
The severity of asthma and the frequency of asthma will be evaluated based on the ISAAC questionnaire
6
Description
Respiratory Acute Infections
Timepoint
Third month,12 months, 24 months, 60 months
Method of measurement
Acute respiratory infections from a wide range of diseases such as throat infections, colds, and tonsillitis, flu, and lower respiratory tract diseases will be separated with the final diagnosis of pneumonia and bronchiolitis.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After completing the research consent form, one symbiotic drop will be given to the family every month. Necessary training on how to store and use drops will be given. The dosage will be given as one cc per day for a period of 12 months.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers under Mashhad University of Medical Sciences
Full name of responsible person
Hamid Ahanchian
Street address
Knowledge and Health City–Shahid Fakouri Blvd- Fakouri, Khorasan Razavi Provience- Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3801
Fax
+98 51 3870 9201
Email
Ahanchianh@mums.ac.ir
Web page address
https://akbar.mums.ac.ir/index.php/fa-contactus
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
University St, Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
٩٩١٩١٩١٧٧٨
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
tafaghodiM@mums.ac.ir
Web page address
Grant name
Grant code / Reference number
4011745
Is the source of funding the same sponsor organization/entity?