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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03770143
Enrollment
90
Registered
2018-12-10
Start date
2016-05-31
Completion date
2016-10-31
Last updated
2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERFeeding with palm olein formula

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Stool consistency10 weeksAmsterdam Infant Stool Scale

Secondary

MeasureTime frameDescription
Bacteria Count10 weeksnumber of the copy of DNA of Intestinal Flora Content

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026