CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Nutramigen with Enflora +1 moredietary
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/NCT01279265
NCT01279265N/ACompleted
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Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Crying, Intestinal Microbiota, and Intestinal Inflammation in Infants With Colic

The University of Texas Health Science Center, Houston·interventional·Posted Jan 19, 2011·Updated Nov 11, 2015

In Brief

A clinical study evaluating Nutramigen with Enflora and Nutramigen A+ for Colic and Inflammation. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This study will compare 2 currently marketed formulas in healthy full term babies: Nutramigen A+ (a hypoallergenic formula) and Nutramigen-Enflora (hypoallergenic formula with Lactobacillus GG (LGG)) during 3 months of formula feeding. The investigators' aims are to compare 3 outcomes in these babies: (1) normal baby crying time; (2) the composition of intestinal microbiota (bacteria in the stool); and (3) a lab test which measures the number of white blood cells in the large intestine (fecal calprotectin). The investigators predict that LGG supplementation (Nutramigen-Enflora) will facilitate its establishment as an important component of the neonatal intestinal microbial community and reduce fecal calprotectin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColic, Inflammation
CountriesUnited States
CollaboratorsMead Johnson Nutrition

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 19, 2011
Enrollment StartSep 1, 2011
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.5 years ago

Interventions

Nutramigen with Enfloradietary

Hypoallergenic formula with probiotic - Lactobacillus GG

Nutramigen A+dietary

Hypoallergenic formula without lactobacillus