Preventive symbiotic administration on the incidence of allergic diseases in children aged 0 to 5 years

Investigating the effect of preventive symbiotic administration on the incidence of allergic diseases in children aged 0 to 5 years, a clinical trial study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211211053351N2

Enrollment

400

Registered

2023-11-25

Start date

2023-12-22

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic diseases in children. Predominantly allergic asthma

Interventions

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 w

Eligibility

Sex/Gender

All

Age

1 Days to 5 Years

Inclusion 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

Exclusion criteria: Abnormalities of the newborn in the cardiac, skeletal, nervous system

Design outcomes

Primary

Measure	Time frame
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 i	—

Measure

Time frame

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 i

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Ahanchian

Mashhad University of Medical Sciences

Ahanchianh@mums.ac.ir+98 51 3871 3801

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026