An observational study in Feeding; Disorder, Nonorganic Origin, Calcium Disorder and Intestinal Bacteria Flora Disturbance, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged Up to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational
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.
186 studies on the registry are indexed under Dysbiosis; 59 are open to participants now.
This study's enrollment of 90 is close to the median of 86 across 48 observational studies indexed under Dysbiosis.
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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.
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
Exclusion Criteria:
Infants feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life
Other: Feeding with palm olein formula
Infants feeding with other formulas including palm olein if presence in addition to breast milk for 8 weeks of life
Having similar demographical properties with infants feeding with breast milk (gender, age, weight, height)
Stool consistency
Amsterdam Infant Stool Scale
Time frame: 10 weeks
Bacteria Count
number of the copy of DNA of Intestinal Flora Content
Time frame: 10 weeks
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Kanuni Sultan Suleyman Training and Research Hospital