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

NCT03770143 | Completed

• 1 other identifier: ANCL034
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Stool consistency

  Amsterdam Infant Stool Scale

  10 weeks

Secondary Outcomes (1)

• Bacteria Count

  10 weeks

Study Arms (3)

Group 1

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

Other: Feeding with palm olein formula

Group 2

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

Group 3

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

Interventions

Feeding with palm olein formula OTHER

Group 1

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

A total of 90 healthy infants (30 under breast-feeding, 30 feeding with palm olein free formula and 30 feeding with palm olein formula) will be included. Infants feeding enterally more than %70 with breast milk will be considered as breast-feeding. Infants who had not adequate weight gain and need formula will be randomized to receive either palm olein or palm olein free term formula in addition to mother milk. Parental informed consent will be taken and infants whose parents give permission will be included.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

Location

Study Officials

• Seda Yilmaz Semerci

  Kanuni SSTRH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD,PhD

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: December 10, 2018
• Study Start: May 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 23, 2019

Record last verified: 2018-12

Locations

TU (1)