NCT01279265

Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic

Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Crying, Intestinal Microbiota, and Intestinal Inflammation in Infants With Colic

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 3 Weeks – 3 Months
• Healthy volunteers: Accepted

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.

Conditions

• Colic
• Inflammation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutramigen with Enflora	Hypoallergenic formula with probiotic - Lactobacillus GG
DIETARY_SUPPLEMENT	Nutramigen A+	Hypoallergenic formula without lactobacillus

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-01-19
• Last updated: 2015-11-11
• Results posted: 2015-11-11

Locations

1 site across 1 country: United States