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Completed

NCT Number: NCT03770143

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

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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Key information

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Feeding with palm olein formula

Other

Primary outcomes

  1. Stool consistency

    Time frame: 10 weeks

    Amsterdam Infant Stool Scale

Secondary outcomes

  1. Bacteria Count

    Time frame: 10 weeks

    number of the copy of DNA of Intestinal Flora Content

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 10, 2018
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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