At a glance

ClinicalIndex Comparison Record

N/ACompleted· 148 enrolled

Drug / intervention

Infant formula with GOS, beta-palmitate, acidified milk +1 moreother

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.

Search/NCT01197365

NCT01197365N/ACompleted

Compare CT.gov

Double-blind Randomized Controlled Study for the Evaluation of Nutritional Outcomes of a Cow's Milk Based Infant Formula Containing Galacto-oligosaccharides, Beta-palmitate and Acidified Milk

Heinz Italia SpA·interventional·Posted Sep 9, 2010·Updated Feb 4, 2015

In Brief

A clinical study evaluating Infant formula with GOS, beta-palmitate, acidified milk and Standard infant formula without functional ingredients for Formula Feeding of Healthy Full Term Infants. Completed, enrolled 148 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with galacto-oligosaccharides (GOS), beta-palmitate and acidified milk in improving the gastrointestinal health and immune response in healthy term infants.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsFormula Feeding of Healthy Full Term Infants

CountriesItaly

CollaboratorsFondazione IRCCS Policlinico San Matteo di Pavia, Centro di Immunità e Nutrizione - Università degli Studi di Pavia (Prof.ssa Annamaria Castellazzi), Advanced Analytical Technologies

Timeline

N/ACompletedFinished

2011201220132014201520162017201820192020202120222023202420252026

Enrollment StartAug 2010

First PostedSep 2010

Primary CompletionMar 2014

Study CompletionDec 2014

TodayJul 2026

First PostedSep 9, 2010

Enrollment StartAug 1, 2010

Primary CompletionMar 1, 2014

Study CompletionDec 1, 2014

TodayJul 2, 2026

Enrollment to primary: 3.6 yearsPosted 15.8 years ago

Interventions

Infant formula with GOS, beta-palmitate, acidified milkother

Infant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk. Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae

Standard infant formula without functional ingredientsother

Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients