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

Kanuni Sultan Suleyman Training and Research Hospital

Status: Completed

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

Treatments: Other: Feeding with palm olein formula

Study type: Observational

Funder types: Other

Identifiers

NCT03770143

ANCL034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: Under 3 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

90 participants in 3 patient groups

Group 1

Description:

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

Treatment:

Other: Feeding with palm olein formula

Group 2

Description:

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

Group 3

Description:

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