Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic

The University of Texas System (UT) logo

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

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+

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems