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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Infant Term Birth

Intervention / Treatment
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* Other: Standard Infant Formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard Infant Formula<br>Standard Infant Formula containing High Sn-2 | Other: Standard Infant Formula<br>* Standard Infant Formula containing High Sn-2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Stool Form Scale | frequency and consistency | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline to 12 weeks in Height centile | height (cm) | 12 weeks | 
| Changes from baseline to 12 weeks in Weight centile | weight(kg) and respective Wt z-scores | 12 weeks | 
| Changes from baseline to 12 weeks in Head Circumference centile | Head circumference (cm) | 12 weeks |