NCT02598817CompletedNot Applicable
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.
Société des Produits Nestlé (SPN)5 sites in 2 countries276 target enrollmentStarted: July 1, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 276
- Locations
- 5
- Primary Endpoint
- Infant Stool Form Scale
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Weeks to 12 Weeks (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Infant Stool Form Scale
Time Frame: 12 weeks
frequency and consistency
Secondary Outcomes
- Changes from baseline to 12 weeks in Height centile(12 weeks)
- Changes from baseline to 12 weeks in Weight centile(12 weeks)
- Changes from baseline to 12 weeks in Head Circumference centile(12 weeks)
Investigators
Study Sites (5)
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