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

Completed

• Conditions: Intestinal Bacteria Flora Disturbance; Calcium Disorder; Feeding; Disorder, Nonorganic Origin
• Interventions: Other: Feeding with palm olein formula

• Registration Number: NCT03770143
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-11
• Primary Completion: 2016-08
• Study Completion: 2016-10
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-10
• Last Update Submitted: 2019-04-22
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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)

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Feeding with palm olein formula	Infants feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life

Primary Outcome Measures

Name	Time	Method
Stool consistency	10 weeks	Amsterdam Infant Stool Scale

Secondary Outcome Measures

Name	Time	Method
Bacteria Count	10 weeks	number of the copy of DNA of Intestinal Flora Content

Trial Locations

Locations (1)

Kanuni Sultan Suleyman Training and Research Hospital; 🇹🇷 Istanbul, Kucukcekmece, Turkey