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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02598817

Enrollment

276

Registered

2015-11-06

Start date

2018-07-01

Completion date

2021-01-05

Last updated

2023-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant Term Birth

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.

Interventions

OTHERStandard Infant Formula

Standard Infant Formula containing High Sn-2

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Weeks to 12 Weeks

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Infant Stool Form Scale	12 weeks	frequency and consistency

Secondary

Measure	Time frame	Description
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)

Countries

Saudi Arabia, United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026