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IRCT20211211053351N2 IRCT 2023-11-25 Mashhad University of Medical Sciences Preventive symbiotic administration on the incidence of allergic diseases in children aged 0 to 5 years MSS (Mashhad symbiotic study) Investigating the effect of preventive symbiotic administration on the incidence of allergic diseases in children aged 0 to 5 years, a clinical trial study 2023-12-22 anticipated 400 Recruiting https://irct.ir/trial/69726 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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 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. N/A Allergic diseases in children. 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.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Hamid Ahanchian
Shahid Fakouri Blvd, Mashhad, Khorasan Razavi Province, Iran
Mashhad Iran (Islamic Republic of) 91778 99191 +98 51 3871 3801 Ahanchianh@mums.ac.ir Mashhad University of Medical Sciences scientific Tahereh Sadeghi
Shahid Fakouri Blvd, Mashhad, Khorasan Razavi Province, Iran
Mashhad Iran (Islamic Republic of) 91778 99191 +98 51 3871 3801 tahereh.sadeghi@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 1 day 5 years Both Abnormalities of the newborn in the cardiac, skeletal, nervous system J45.0 Predominantly allergic asthma Prevention 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. 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. 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). 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. 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.​. ََ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. 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. Zisttakhmir Co Approved 2023-09-09 Research Ethics Committees of Mashhad University of Medical Sciences Knowledge and Health City, In the end of Shahid Fakouri Blvd (In front of Fakouri ٩۴), Mashhad - Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)