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

Infant Term Birth Clinical Trial

Official title:

Acceptability of "High Sn-2" Infant Formula in Non-Breast Fed Healthy Term Infants Regarding Gastrointestinal Tolerability by Both Parents and Pediatrician. An Open Label Pilot Study Evaluation in the Gulf Cooperation Council (GCC) Countries.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598817
• Other study ID #: 15.17.INF.ME
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: January 5, 2021

Study information

• Verified date: February 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: January 5, 2021
• Est. primary completion date: January 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Weeks to 12 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Infant Term Birth

Intervention

Other:
• Standard Infant Formula
Standard Infant Formula containing High Sn-2

Locations

Country	Name	City	State
Saudi Arabia	Almana Hospital	Al Jubayl
Saudi Arabia	Tadawi General Hospital	Dammam
Saudi Arabia	Al Mouasat Hospital	Riyadh
United Arab Emirates	Sheikh Khalifa Medical City	Abou Dabi
United Arab Emirates	Al Garhoud Private Hospital	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Countries where clinical trial is conducted

Saudi Arabia,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant Stool Form Scale	frequency and consistency	12 weeks
Secondary	Changes from baseline to 12 weeks in Height centile	height (cm)	12 weeks
Secondary	Changes from baseline to 12 weeks in Weight centile	weight(kg) and respective Wt z-scores	12 weeks
Secondary	Changes from baseline to 12 weeks in Head Circumference centile	Head circumference (cm)	12 weeks