Association of HMOs and Allergic Manifestations

Human Milk Oligosaccharides, Allergic Manifestation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03256370
• Other study ID #: HMOs
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2017
• Last updated: October 15, 2017
• Start date: November 1, 2017
• Est. completion date: October 5, 2019

Study information

• Verified date: April 2017
• Source: Chulalongkorn University
• Contact: Narissara Suratannon, MD
• Phone: 662-256-4933
• Email: narissara.su[@]chula.ac.th
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 5, 2019
• Est. primary completion date: October 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Milk Oligosaccharides, Allergic Manifestation

Intervention

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

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Pathum Wan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	IgE mediated food allergy	confirmed by oral food challenge	first 2 years of life
Primary	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