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

Completed

• Conditions: Infant Term Birth
• Interventions: Other: Standard Infant Formula

• Registration Number: NCT02598817
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-06
• Study Start: 2018-07-01
• Primary Completion: 2020-01-08
• Study Completion: 2021-01-05
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard Infant Formula	Standard Infant Formula	Standard Infant Formula containing High Sn-2

Primary Outcome Measures

Name	Time	Method
Infant Stool Form Scale	12 weeks	frequency and consistency

Secondary Outcome Measures

Name	Time	Method
Changes from baseline to 12 weeks in Height centile	12 weeks	height (cm)
Changes from baseline to 12 weeks in Weight centile	12 weeks	weight(kg) and respective Wt z-scores
Changes from baseline to 12 weeks in Head Circumference centile	12 weeks	Head circumference (cm)

Trial Locations

Locations (5)

Tadawi General Hospital; 🇸🇦 Dammam, Saudi Arabia

Almana Hospital; 🇸🇦 Al Jubayl, Saudi Arabia

Al Mouasat Hospital; 🇸🇦 Riyadh, Saudi Arabia

Al Garhoud Private Hospital; 🇦🇪 Dubai, United Arab Emirates

Sheikh Khalifa Medical City; 🇦🇪 Abou Dabi, United Arab Emirates