Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic

Completed · Not applicable

Conditions studied: Colic, Inflammation

In brief

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.

Key facts

Study ID

NCT01279265

Run by

The University of Texas Health Science Center, Houston

People needed

30

Starts

2011-09-01

Expected to finish

2013-01-01

Last updated by the study team

2015-11-11

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Sixty healthy full-term colicky infants (gestational age 32 wks to 41 wks)

You may not qualify if…

• chronic lung disease,
• diarrhea (stools that take the shape of a container > 5x daily)
• fever

Where it is running

• University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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