Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic

The University of Texas System (UT)

Status: Completed

Conditions: Inflammation; Colic

Treatments: Dietary Supplement: Nutramigen A+; Dietary Supplement: Nutramigen with Enflora

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01279265

HSC-MS-10-0048

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 3 weeks to 3 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Nutramigen Lipil with Enflora

Active Comparator group

Description:

Formula with probiotics (Lactobaccillus Rhamnosus GG)

Treatment:

Dietary Supplement: Nutramigen with Enflora

Nutramigen A+

Placebo Comparator group

Description:

Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG)

Treatment:

Dietary Supplement: Nutramigen A+