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Depending on recent studies in literature the investigators aimed to compare whether gastrointestinal tolerance differs between infants fed with palm olein containing or palm olein free formulas. Besides it is showed that palm olein containing formulas decreases the absorption of fat and calcium by forming insoluble calcium soaps. So it is suggested that intestinal flora might be affected as a reason of these specialties. This study also aimed to investigate with culture-independent methods whether feeding infants with palm olein free formula results in the modification of their intestinal microbiota in such a way that is similar to breastfed ones.
Recent studies in literature the investigators aimed to compare whether gastrointestinal tolerance differs between infants fed with palm olein containing or palm olein free formulas. Besides it is showed that palm olein containing formulas decreases the absorption of fat and calcium by forming insoluble calcium soaps. So it is suggested that intestinal flora might be affected as a reason of these specialties. This study also aimed to investigate with culture-independent methods whether feeding infants with palm olein free formula results in the modification of their intestinal microbiota in such a way that is similar to breastfed ones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Infants feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life |
| |
| Group 2 | Infants feeding with other formulas including palm olein if presence in addition to breast milk for 8 weeks of life | ||
| Group 3 | Having similar demographical properties with infants feeding with breast milk (gender, age, weight, height) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feeding with palm olein formula | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stool consistency | Amsterdam Infant Stool Scale | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bacteria Count | number of the copy of DNA of Intestinal Flora Content | 10 weeks |
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Inclusion Criteria:
The data of the patients who fulfilled the following criteria are evaluated.
Term infants between 38 and 40 weeks of gestational age and/or with a birth weight of > 2500grams who are either breastfed or formula fed.
Selection of the subgroup using oral nutrition
Feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life
Feeding with other formulas including palm olein if presence in addition to breast milk for 8 weeks of life Selection of the subgroup not using oral nutritional supplement (control group)
Having similar demographical properties with infants feeding with breast milk (gender, age, weight, height)
Exclusion Criteria:
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A total of 90 healthy infants (30 under breast-feeding, 30 feeding with palm olein free formula and 30 feeding with palm olein formula) will be included. Infants feeding enterally more than %70 with breast milk will be considered as breast-feeding. Infants who had not adequate weight gain and need formula will be randomized to receive either palm olein or palm olein free term formula in addition to mother milk. Parental informed consent will be taken and infants whose parents give permission will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Seda Yilmaz Semerci | Kanuni SSTRH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanuni Sultan Suleyman Training and Research Hospital | Istanbul | Kucukcekmece | 34303 | Turkey (Türkiye) |
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