At a glance
ClinicalIndex Comparison RecordN/ACompleted· 360 enrolled
Drug / intervention
Infant formula (with GOS)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double Blind Study to Evaluate the Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS) in Healthy, Full Term Infants
In Brief
A clinical study evaluating Infant formula (with GOS) for Nutritional Safety. Completed, enrolled 360 participants across 7 sites.
Detailed Summary
The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with a "prebiotic" component (GOS) in improving the gut microflora balance, mimicking that of breast-fed infants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNutritional Safety
CountriesItaly
Collaborators--
Timeline
N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2006
First PostedJun 2007
Primary CompletionOct 2011
Study CompletionJun 2013
TodayJul 2026
First PostedJun 13, 2007
Enrollment StartFeb 1, 2006
Primary CompletionOct 1, 2011
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 19.1 years ago
Interventions
Infant formula (with GOS)other
Infant formula supplemented with 0.4 g/100 ml of galacto-oligosaccharides