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CTRI Number  CTRI/2024/07/070356 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Food Allergen Sensitisation in Children Aged 5-18 with Respiratory Allergic Diseases: A One-Year CrossSectional Study Using the EAST Method in a Tertiary Care Hospital 
Scientific Title of Study   Study of food allergens sensitization in children between age of 5-18 years with respiratory allergic diseases using EAST( enzyme allergo sorbent test) method- a one year hospital based cross sectional study in tertiary care centre 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shraddha Gupta 
Designation  Paediatric Resident 
Affiliation  JNMC belgavi  
Address  Department of paediatric, Jawaharlal Nehru Medical College,KLE hospital road, Belgaum, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  6360371383  
Fax    
Email  shraddhagupta1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dnyanesh DK 
Designation  Professor and HOD 
Affiliation  Jawaharlal Nehru medical college, KLE UNIVERSITY 
Address  Department of paediatric, Jawaharlal Nehru Medical College, Nehru nagar, KLE hospital road

Belgaum
KARNATAKA
591113
India 
Phone  9538123244  
Fax    
Email  drdnyaneshk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shraddha Gupta  
Designation  Md Paediatrics  
Affiliation  Jawaharlal Nehru medical college, KLE UNIVERSITY 
Address  Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, Kle hospital road, Belgaum

Belgaum
KARNATAKA
591113
India 
Phone  9538123244  
Fax    
Email  shraddhagupta1998@gmail.com  
 
Source of Monetary or Material Support  
KLE dr Prabhakar kore hospital, Jawaharlal Nehru medical college, KLE university, belgavi 
 
Primary Sponsor  
Name  Jawaharlal nehru Medical College kle University belgaum 
Address  Department of Paediatrics, Jawaharlal nehru Medical College, nehru nagar, belgaum, Karnataka, 590010 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shraddha gupta  KLEs Dr Prabhakar Kore hospital, Jawaharlal Nehru Medical College, Kle University, belgavi  Department of paediatrics, KLEs Dr Prabhakar Kore hospital, Jawaharlal Nehru medical college , belgaum
Belgaum
KARNATAKA 
6360371383

shraddhagupta1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J453||Mild persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children between 5- 18 years of age who are a known case of Allergic airway disease

- Children between 5-18 years of age who are a known case of bronchial asthma

-Children between 5- 18 years of age who are a known case of allergic rhinitis 
 
ExclusionCriteria 
Details  Children in the age group 5-18 years of age with acute lower respiratory tract infection

Children in age group 5-18 years of age on oral steroid therapy and/or immunosupressants 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Determine the prevalence of food allergen sensitization in children diagnosed with respiratory allergy disease  The study will be conducted over a span of 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1. Identify specific food allergen most commonly associated with respiratory allergic diseases

2. Explore potential correlations with the severity of respiratory symptoms and degree of food allergen sensitization 
The study will be conducted over a span of 1 year 
 
Target Sample Size   Total Sample Size="61"
Sample Size from India="61" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

In India, the frequency of immune-mediated illnesses such as allergic airway diseases is rising. Compared to the global average of 7, India has a 2.4-fold higher Death and Disability Associated Life Years (DALY) per case of asthma. Early food sensitization during infancy increases the risk of developing respiratory allergic diseases, including asthma and allergic rhinitis, which account for 10-53% and 29% of cases, respectively, of food sensitization. The most frequently reported dietary allergies were peanuts, milk, and shellfish. Common food allergies in the West include hazelnuts, fruits, and peanuts. The bulk of published research on atopy and allergy disorders originates from high-income English-speaking countries and may not be immediately applicable to low-middle income countries like India due to fundamental differences in genetic, environmental, and lifestyle factors. The use of more recent, less invasive techniques, such as serum IgE antibody detection, has shown to be more sensitive and specific in detecting allergen sensitization profiles, particularly when monitoring the profiles and identifying polysensitization to multiple allergens. There is no scientific evidence to support parents’ concerns that food will harm their child when their child has a respiratory allergy disease, so it’s crucial to inform them of this fact. These parents would benefit from psychological and cognitive therapy to help them strike a balance between the child’s safety and enjoying almost daily life. This study is necessary because, in contrast to more antiquated techniques used in daily practice, it employs a quicker method to identify sensitization profiles of kids with a documented history of allergic airway disease. 

 
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