Clinical trial NCT03770143: Evaluation of the Effect of Palm Olein Free Formula on Intestinal Flora and Gastrointestinal Tolerance
Official title: Evaluation of the Effect of Palm Olein Free Formula on Intestinal Flora and Gastrointestinal Tolerance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Feeding; Disorder, Nonorganic Origin
Calcium Disorder
Intestinal Bacteria Flora Disturbance
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 90
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

The data of the patients who fulfilled the following criteria are evaluated.

1. 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
2. Feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life
3. 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)
4. Having similar demographical properties with infants feeding with breast milk (gender, age, weight, height)

Exclusion Criteria:

* Infants with major congenital abnormalities will be excluded.
* Infants with lack of data will also be excluded.
* Infants, whose parents don't agree with informed consent, will be excluded.

Primary outcomes:
measure: Stool consistency
timeFrame: 10 weeks
Secondary outcomes:
measure: Bacteria Count
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
state: Kucukcekmece
Study officials:
affiliation: Kanuni SSTRH
name: Seda Yilmaz Semerci
role: STUDY_DIRECTOR
References: