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Relationship between maternal diet, breast milk composition and offspring's microbiome and nutritional status in Malaysia


- candidate number16120
- NTR NumberNTR4404
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jan-2014
- Secondary IDsP827776 
- Public TitleRelationship between maternal diet, breast milk composition and offspring's microbiome and nutritional status in Malaysia
- Scientific TitleRelationship between maternal diet, breast milk composition, and offspring's microbiome and nutritional status in Malaysia
- ACRONYM
- hypothesisDoes maternal diet influence the child’s intestinal microbiome via breast milk?
- Healt Condition(s) or Problem(s) studiedInfants, Breastfeeding , microbiomics, Diet
- Inclusion criteriaMalay mothers aged 20-40 yr of Middle economic status who are Breastfeeding infants (from 2 wks onwards) Preferably exclusive breastfeeding
- Exclusion criteriaNon-Malay Ill during breastmilk collection Mothers on a special diet
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2013
- planned closingdate1-nov-2014
- Target number of participants40
- InterventionsBreast milk samples will be collected at three different times and will be analyzed for minerals, vitamins, protein, fat, lactose and fiber. Fecal samples for metabolic profiling will be collected from the infant around the same period of the breast milk collection. Info on dietary intake of the mother will be collected through food frequency questionnaire and a 24 h food recall interview. Weight, length, and head circumference of the infant will be measured.
- Primary outcomelink(s) between maternal diet and breast milk composition
- Secondary outcomelink(s) between breast milk composition and infant's microflora
- TimepointsEach mother-infant couple will be included for 4-6 weeks. There will be 3 collections time points: t1=0, t2=2-3 weeks, and t3=5-6 weeks.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES I.M.S. Tan-Khouw
- CONTACT for SCIENTIFIC QUERIES I.M.S. Tan-Khouw
- Sponsor/Initiator International Medical University
- Funding
(Source(s) of Monetary or Material Support)
FrieslandCampina
- Publications
- Brief summaryIt is well established that breast milk composition differs from mother to mother. There is compiling evidence that the maternal diet (life long and short term) has an enormous effect on breast milk composition. Since breast milk is a strong determinant for the type of intestinal microbiome to develop in the infant during the breastfeeding period, and this developed microbiome is considered to have a relevant impact on the microbiome at older age, this study will examine faecal samples from the breast fed infants. As maternal diet exerts a strong influence on the composition of breast milk and the child’s intestinal microbiome, maternal and child dietary intakes will be investigated.
- Main changes (audit trail)
- RECORD21-jan-2014 - 7-apr-2014


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