Evaluation of the Effect of Palm Olein Free Formula on Intestinal Flora and Gastrointestinal Tolerance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Feeding; Disorder, Nonorganic Origin Calcium Disorder Intestinal Bacteria Flora Disturbance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Infants feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life

Feeding with palm olein formula

Intervention Type OTHER

Group 2

Infants feeding with other formulas including palm olein if presence in addition to breast milk for 8 weeks of life

No interventions assigned to this group

Group 3

Having similar demographical properties with infants feeding with breast milk (gender, age, weight, height)

No interventions assigned to this group

Interventions

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Feeding with palm olein formula

Intervention Type OTHER

Eligibility Criteria

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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.

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes