Association of HMOs and Allergic Manifestations

Study Overview
=================
Brief Summary
-----------------
Compare the HMO composition in breast milk of infants with allergic manifestation (atopic dermatitis and food allergy) in the first 3 years of life, healthy infants with allergic mother and healthy infants with non-allergic mother.

Detailed Description
-----------------
Parents of breast-fed infant from general pediatric clinic and allergy clinic of King Chulalongkorn Memorial Hospital were approached for informed about the research and ask to join this project After completed informed consent, demographic data was collected and filled in case record form Milk of mother in both allergic and control groups were collected 60 ml then transferred to freeze at -80oc to for human milk oligosaccharide analysis

Official Title
-----------------
The Association Between Human Milk Oligosaccharide and Development of Allergic Manifestations in Infants

Conditions
-----------------
Human Milk Oligosaccharides, Allergic Manifestation

Intervention / Treatment
-----------------
* Procedure: milk collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mothers with breast-fed infant with or without allergic manifestation Intend to participate for follow up and sign consent to participate in the study Exclusion Criteria: Mothers with any medical illness or high risk infant pregnant Infants with disease which affected allergic disease No inform consent Anything in the opinion of the investigator that would prevent children from completing the study

Ages Eligible for Study
-----------------
Maximum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants with allergic diseases<br>allergic disease : atopic dermatitis or food allergy | Procedure: milk collection<br>* Parents of breast-fed infant from general pediatric clinic and allergy clinic of King Chulalongkorn Memorial Hospital were approached for informed about the research and ask to join this project After completed informed consent, demographic data was collected and filled in case record form Milk of mother in both allergic and control groups were collected 60 ml then transferred to freeze at -80oc to for human milk oligosaccharide analysis Method of human milk oligosaccharide analysis : Ultra High Pressure Liquid Chromatography(UHPLC) with fluorescence method High-Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD) method<br>|
| Healthy infants with atopic mothers<br>atopic mothers : mothers with asthma or allergic rhinitis or allergic dermatitis (diagnosed by doctors) | Procedure: milk collection<br>* Parents of breast-fed infant from general pediatric clinic and allergy clinic of King Chulalongkorn Memorial Hospital were approached for informed about the research and ask to join this project After completed informed consent, demographic data was collected and filled in case record form Milk of mother in both allergic and control groups were collected 60 ml then transferred to freeze at -80oc to for human milk oligosaccharide analysis Method of human milk oligosaccharide analysis : Ultra High Pressure Liquid Chromatography(UHPLC) with fluorescence method High-Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD) method<br>|
| Healthy infants with non-atopic mothers.<br>non-atopic mothers : mothers without history of asthma or allergic rhinitis or allergic dermatitis | Procedure: milk collection<br>* Parents of breast-fed infant from general pediatric clinic and allergy clinic of King Chulalongkorn Memorial Hospital were approached for informed about the research and ask to join this project After completed informed consent, demographic data was collected and filled in case record form Milk of mother in both allergic and control groups were collected 60 ml then transferred to freeze at -80oc to for human milk oligosaccharide analysis Method of human milk oligosaccharide analysis : Ultra High Pressure Liquid Chromatography(UHPLC) with fluorescence method High-Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD) method<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atopic dermatitis | Relapsing eczematous typical morphology on typical distribution (Scalp, face, neck, and extensor surfaces of the skin) Typical morphology Acute and subacute : erythematous papules and plaques, may vesiculate and become exudative Chronic : lichenification, papules and excoriations | first 2 years of life | 
| IgE mediated food allergy | confirmed by oral food challenge | first 2 years of life | 
| Non-IgE mediated food allergy | Presentation of clinical ex. bloody stool when repeating episode occurred with the same food more than twice. Improvement of symptom after eliminating of suspected food | first 2 years of life | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic manifestation, Human milk oligosaccharides, Breast Milk