Association of HMOs and Allergic Manifestations

• Conditions: Human Milk Oligosaccharides, Allergic Manifestation
• Interventions: Procedure: milk collection

• Registration Number: NCT03256370
• Lead Sponsor: Chulalongkorn University

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

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-22
• Last Update Submitted: 2017-10-15
• Last Update Posted: 2017-10-17
• Study Start: 2017-11-01
• Primary Completion: 2018-10-05
• Study Completion: 2019-10-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. mothers with breast-fed infant with or without allergic manifestation
2. Intend to participate for follow up and sign consent to participate in the study

Exclusion Criteria

1. Mothers with any medical illness or high risk infant pregnant
2. Infants with disease which affected allergic disease
3. No inform consent
4. Anything in the opinion of the investigator that would prevent children from completing the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy infants with atopic mothers	milk collection	atopic mothers : mothers with asthma or allergic rhinitis or allergic dermatitis (diagnosed by doctors)
Infants with allergic diseases	milk collection	allergic disease : atopic dermatitis or food allergy
Healthy infants with non-atopic mothers.	milk collection	non-atopic mothers : mothers without history of asthma or allergic rhinitis or allergic dermatitis

Primary Outcome Measures

Name	Time	Method
Atopic dermatitis	first 2 years of life	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
IgE mediated food allergy	first 2 years of life	confirmed by oral food challenge
Non-IgE mediated food allergy	first 2 years of life	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

Trial Locations

Locations (1)

Chulalongkorn University; 🇹🇭 Pathum Wan, Bangkok, Thailand