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Evaluation of the Effect of Palm Olein Free Formula on Intestinal Flora and Gastrointestinal Tolerance | Clinical Trials | Clareo Health

COMPLETED

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

NCT03770143•Kanuni Sultan Suleyman Training and Research Hospital

View on ClinicalTrials.gov

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

Age

0 - 0 years

Sex

ALL

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.

Locations (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Kucukcekmece, Turkey (Türkiye)

Key Dates

Start Date

May 1, 2016

Primary Completion Date

August 1, 2016

Completion Date

October 1, 2016

Last Updated

April 23, 2019

Enrollment

ACTUAL participants

Conditions

Feeding; Disorder, Nonorganic OriginCalcium DisorderIntestinal Bacteria Flora Disturbance

Interventions

Feeding with palm olein formula

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.

The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses

Multi-Antibiotic Resistance Carriage in Gut Flora