| 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
|
|
|
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
|
|
|
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. |