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Maternal Ethnic Group,Diet,Breast Milk Fatty Acid and Potential Effect Development of Allergy in the Offspring

18. september 2009 opdateret af: National University Hospital, Singapore

The Influence of Maternal Ethnic Group and Diet on Breast Milk Fatty Acid Content and Its Potential Effect on Development of Allergy in the Offspring.

Women of different ethnic groups have different diets that may affect the fatty acid content of their breast milk. Ethnicity may also have an independent effect on breast milk composition. The differences in fatty acid content of breast milk may influence the immune tolerance of breastfed babies, and hence the development of allergy.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Pregnant women with the intention of breastfeeding their babies will be recruited about 36 weeks of gestation. After informed written consent has been obtained, a standard questionnaires will be applied to determine their demographic particulars, family of atopy and environmental details. A trained research coordinator will then profile their diet using a standard validated food frequency questionnaire (FFQ).

After delivery, these mothers will be helped to initiate, establish and continue breastfeeding. Details of their deliveries and the babies' birth measurements will be documented. A breastfeeding diary and infant/child health diary will be given to the mothers to record their breastfeeding practice as well as their child's health status.

The mothers will be followed up in the hospital before discharge, at the postnatal clinic at 1 and 6 weeks, and at 3,6 and 12 months. The mother's blood (1 ml) will be taken at 1 and 6 weeks and breast milk (20 mls) will be collected at 1 week, 6 weeks, 3 months, 6 and 12 months after delivery (as long as mothers breastfeeds).The maternal serum and breast milk total lipids will be extracted and fractionated using micro-extraction and semi-preparative liquid chromatography fraction methods. The fatty acid methyl esters will be separated, using liquid chromatography and capillary electrophoresis coupled mass spectrometry, and tje n-6 and n-3 fatty acid methyl esters identified by comparison with retention times and mass charge ratio information of pure reference substances (sigma Aldrich Sweden AB,Stockholm, Sweden).

The babies of the mothers will be followed up at 1week,6 weeks,3,6,and 12 months of age. At each visit, mothers will answer standard (ISSAC)allergy questionnaires, infant feeding patterns, hygiene practice and child's growth and development parameters: height and weight.At 12 months of age, skin prick testing will performed on the child. This method of detecting atopy is less invasive and gives faster results than measuring serum IgE levels. Our skin prick test protocol follows the routine panel used in NUH's Paediatric Allergy Clinic for under 3 years old viz. Dermatophagoides pteronyssinus (dustmite), Blomia tropicalis (dustmite), cat dander, egg white, soy protein, cow's milk, histamine positive control and saline negative control. Size of wheal and /or erythema when present will be recorded.

The fatty acid analysis of human breast milk have a very low coefficient of variation of about 2% for most of the important fatty acids and therefore 300 mothers and infants will be enough for this pilot study.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Singapore, Singapore, 119074
        • National University Hospital, Singapore

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Pregnant women with the intention of breastfeeding their babies

Beskrivelse

Inclusion Criteria:

  • Pregnant women of about 36 weeks gestation with the intention of breastfeeding their babies.

Exclusion Criteria:

  • Nil

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Dr Chong Yap Seng, MBBS, National University Hospital, Singapore

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2003

Studieafslutning (Faktiske)

1. februar 2006

Datoer for studieregistrering

Først indsendt

1. marts 2006

Først indsendt, der opfyldte QC-kriterier

1. marts 2006

Først opslået (Skøn)

2. marts 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. september 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. september 2009

Sidst verificeret

1. september 2009

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RPR/NHG/03025

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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