Human Milk Oligosaccharides, Allergic ManifestationNCT03256370
Association of HMOs and Allergic Manifestations
An observational study of Human Milk Oligosaccharides, Allergic Manifestation, run by Chulalongkorn University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages Up to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Milk Oligosaccharides, Allergic Manifestation
- What is being tested?
- milk collection
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2017to 5 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- mothers with breast-fed infant with or without allergic manifestation
- Intend to participate for follow up and sign consent to participate in the study
Who cannot join
- Mothers with any medical illness or high risk infant pregnant
- Infants with disease which affected allergic disease
- No inform consent
- Anything in the opinion of the investigator that would prevent children from completing the study
Trial locations and contacts
1 site in 1 country.
Jintana Chataroopwijit, MD contact
Thailand1 site, 1 recruiting
- Recruiting
Chulalongkorn University
Pathum Wan, Bangkok, 10330
Narissara Suratannon, MD, 668-1295-0190, narissara.su@chula.ac.th
About this study
Official title: 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.
Read the 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
- Being tested
- milk collection
- Keywords
- Allergic manifestation, Human milk oligosaccharides, Breast Milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milk collectionProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| Infants with allergic diseases | allergic disease : atopic dermatitis or food allergy Receives: Procedure: milk collection | |
| Healthy infants with atopic mothers | atopic mothers : mothers with asthma or allergic rhinitis or allergic dermatitis (diagnosed by doctors) Receives: Procedure: milk collection | |
| Healthy infants with non-atopic mothers. | non-atopic mothers : mothers without history of asthma or allergic rhinitis or allergic dermatitis Receives: Procedure: milk collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: first 2 years of life
IgE mediated food allergy
confirmed by oral food challenge
Measured: 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
Measured: first 2 years of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start1 Nov 2017 (estimated)
- Primary completion5 Oct 2018 (estimated)
- Study completion5 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Milk Oligosaccharides, Allergic ManifestationStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256370
- Sponsor's protocol ID
- HMOs
- Status last verified
- Apr 2017
- First submitted
- 11 Aug 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Human Milk Oligosaccharide and Development of Allergic Manifestations in Infants
- ClinicalTrials.gov ID
- NCT03256370
- Acronym / sponsor ID
- HMOs
- Keywords
- Allergic manifestation, Human milk oligosaccharides, Breast Milk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 5 Oct 2018 (estimated)
- Study completion
- 5 Oct 2019 (estimated)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infants with allergic diseases | – | Procedure: milk collectionallergic disease : atopic dermatitis or food allergy |
| Healthy infants with atopic mothers | – | Procedure: milk collectionatopic mothers : mothers with asthma or allergic rhinitis or allergic dermatitis (diagnosed by doctors) |
| Healthy infants with non-atopic mothers. | – | Procedure: milk collectionnon-atopic mothers : mothers without history of asthma or allergic rhinitis or allergic dermatitis |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- mothers with breast-fed infant with or without allergic manifestation
- Intend to participate for follow up and sign consent to participate in the study
Key exclusion criteria (4 listed)
- Mothers with any medical illness or high risk infant pregnant
- Infants with disease which affected allergic disease
- No inform consent
- Anything in the opinion of the investigator that would prevent children from completing the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Healthy infants with atopic mothers, Healthy infants with non-atopic mothers., Infants with allergic diseases |
Primary outcome
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
IgE mediated food allergy
Time frame: first 2 years of life
confirmed by oral food challenge
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jintana Chataroopwijit, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Milk Oligosaccharides, Allergic Manifestation, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Narissara Suratannon, MD (662-256-4933, narissara.su@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atopic dermatitis (time frame: first 2 years of life). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.