Association of HMOs and Allergic Manifestations

October 15, 2017 updated by: Chulalongkorn University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Thailand
    • Bangkok
      • Pathum Wan, Bangkok, Thailand, 10330
        • Recruiting
        • Chulalongkorn University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 :

  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)
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 :

  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
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 :

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Atopic dermatitis
Time Frame: 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
first 2 years of life
IgE mediated food allergy
Time Frame: first 2 years of life
confirmed by oral food challenge
first 2 years of life
Non-IgE mediated food allergy
Time Frame: 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
first 2 years of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HMOs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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