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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

276 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2021-01-05

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.

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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.

Conditions

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Infant Term Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard Infant Formula

Standard Infant Formula containing High Sn-2

Standard Infant Formula

Intervention Type OTHER

Standard Infant Formula containing High Sn-2

Interventions

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Standard Infant Formula

Standard Infant Formula containing High Sn-2

Intervention Type OTHER

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

Minimum Eligible Age

2 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes