Acceptability and Gastrointestinal Tolerance of a High-Sn-2 Infant Formula

Société des Produits Nestlé (SPN)276 enrolled

Overview

The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal (GI) Tolerance.

This is a multicenter, open label, observation study; 500 formula fed infants are planned to be enrolled from a network of general pediatricians in the Gulf countries (UAE, Kuwait, Qatar, and KSA). Eligible infants will consume a high sn-2 palmitate infant formula for 12 weeks. All enrolled infants will be evaluated at enrollment and at 4 weeks and 12 weeks.

Study Type

OBSERVATIONAL

Enrollment

276

Conditions

Infant Term Birth

Interventions

Standard Infant FormulaOTHER

Standard Infant Formula containing High Sn-2

Eligibility

Sex: ALLMin age: 2 WeeksMax age: 12 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Formula fed healthy full term infants with normal birth weight (2500g 4000g) * Partially breast and formula fed infants who drink at least 2 formula feedings per day; each to be at least 30ml * Infants of both genders at age of 2 weeks to 12 weeks * Infants of parents providing written informed consent before any study related activities are carried out Exclusion Criteria: * Preterm or IUGR babies * Contraindication of standard infant formula * Infants who have allergy of cow's milk protein * Infants with Serious medical or surgical GI disease * Infants with multiple congenital anomalies * Infants with suspected chromosomal or metabolic disorder * Infants of mothers with a health condition or socioeconomic problems that may interfere with their ability to take care of their infants * Infants of parents who refuse to participate in the study

Locations (5)

Tadawi General Hospital

Dammam, Saudi Arabia

Almana Hospital

Jubail, Saudi Arabia

Al Mouasat Hospital

Riyadh, Saudi Arabia

Sheikh Khalifa Medical City

Abu Dhabi, United Arab Emirates

Al Garhoud Private Hospital

Outcomes

Primary Outcomes

Infant Stool Form Scale

frequency and consistency

Time frame: 12 weeks

Secondary Outcomes

Changes from baseline to 12 weeks in Height centile

height (cm)

Time frame: 12 weeks

Changes from baseline to 12 weeks in Weight centile

weight(kg) and respective Wt z-scores

Time frame: 12 weeks

Changes from baseline to 12 weeks in Head Circumference centile

Head circumference (cm)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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