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

Intestinal Bacteria Flora Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770143
• Other study ID #: ANCL034
• Status: Completed
• Start date: May 2016
• Est. completion date: October 2016

Study information

• Verified date: December 2018
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Calcium Disorder
• Disease
• Dysbiosis
• Feeding; Disorder, Nonorganic Origin
• Intestinal Bacteria Flora Disturbance

Intervention

Other:
• Feeding with palm olein formula

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul	Kucukcekmece

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool consistency	Amsterdam Infant Stool Scale	10 weeks
Secondary	Bacteria Count	number of the copy of DNA of Intestinal Flora Content	10 weeks