Association of HMOs and Allergic Manifestations

NCT ID: NCT03256370

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-10-05

Brief Summary

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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

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* 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

Conditions

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Human Milk Oligosaccharides, Allergic Manifestation

Keywords

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Allergic manifestation, Human milk oligosaccharides, Breast Milk

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Infants with allergic diseases

allergic disease : atopic dermatitis or food allergy

milk collection

Intervention Type PROCEDURE

* 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 :

1. Ultra High Pressure Liquid Chromatography(UHPLC) with fluorescence method
2. 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)

milk collection

Intervention Type PROCEDURE

* 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 :

1. Ultra High Pressure Liquid Chromatography(UHPLC) with fluorescence method
2. 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

milk collection

Intervention Type PROCEDURE

* 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 :

1. Ultra High Pressure Liquid Chromatography(UHPLC) with fluorescence method
2. High-Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD) method

Interventions

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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 :

1. Ultra High Pressure Liquid Chromatography(UHPLC) with fluorescence method
2. High-Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD) method

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chulalongkorn University

Pathum Wan, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Narissara Suratannon, MD

Role: CONTACT

Phone: 662-256-4933

Email: [email protected]

Jintana Chataroopwijit, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Narissara Suratannon, MD

Role: primary

Other Identifiers

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HMOs

Identifier Type: -

Identifier Source: org_study_id