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Clinical Trial Summary

- The primary objective of the study was to compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) of infants randomized to receive either standard formula, or 1 of 2 innovative formulas containing a new fat blend or the new fat blend plus fiber.

- The secondary objectives were to evaluate among the feeding groups, stool characteristics (stool consistency and frequency), GI tolerance assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ), and urinary markers (F2-isoprostanes and 8-hydroxy-2'-deoxyguanosine [8-OHdG], and urine osmolality and specific gravity).

- The primary safety objective was to describe the frequency of adverse events (AEs) among the formula-fed (FF) groups.

- The secondary safety objective was to describe anthropometric measures (weight, length, and head circumference) among the feeding groups.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02031003
Study type Interventional
Source Nestlé
Contact
Status Completed
Phase N/A
Start date September 2010
Completion date December 2011

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