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

Nestlé

Status: Completed

Conditions: Infant Term Birth

Treatments: Other: Standard Infant Formula

Study type: Observational

Funder types: Industry

Identifiers

NCT02598817

15.17.INF.ME

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 276 patients

Sex: All

Ages: 2 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

276 participants in 1 patient group

Standard Infant Formula

Description:

Standard Infant Formula containing High Sn-2

Treatment:

Other: Standard Infant Formula