Association of HMOs and Allergic Manifestations

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

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.

Study Overview

• Status: Unknown
• Conditions: Human Milk Oligosaccharides, Allergic Manifestation
• Intervention / Treatment: Procedure: milk collection

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Narissara Suratannon, MD; Phone Number: 662-256-4933; Email: narissara.su@chula.ac.th
• Study Contact Backup: Name: Jintana Chataroopwijit, MD; Email: Drjintana43@hotmail.com

Study Locations

• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • Recruiting
      • Chulalongkorn University
      • Contact: Narissara Suratannon, MD; Phone Number: 668-1295-0190; Email: narissara.su@chula.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Normal term children (born after 37 weeks gestation) from low risk healthy pregnant women aged 18-40 years divided to 3 groups i. Allergic groups : infants with allergic manifestation ii. High risk control groups : atopic mother with infant no disease iii. Healthy control groups : non- atopic mother with infant no disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

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

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2017
• Primary Completion (ANTICIPATED): October 5, 2018
• Study Completion (ANTICIPATED): October 5, 2019

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (ACTUAL): August 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2017
• Last Update Submitted That Met QC Criteria: October 15, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Allergic manifestation, Human milk oligosaccharides, Breast Milk
• Other Study ID Numbers: HMOs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED