Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic

Not Applicable

Completed

• Conditions: Colic; Inflammation
• Interventions: Dietary Supplement: Nutramigen with Enflora; Dietary Supplement: Nutramigen A+

• Registration Number: NCT01279265
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-12
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-19
• Study Start: 2011-09
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2015-06-11
• Status Verified: 2015-10
• Results First Submitted QC: 2015-10-07
• Last Update Submitted: 2015-10-07
• Results First Posted: 2015-11-11
• Last Update Posted: 2015-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutramigen Lipil with Enflora	Nutramigen with Enflora	Formula with probiotics (Lactobaccillus Rhamnosus GG)
Nutramigen A+	Nutramigen A+	Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG)

Primary Outcome Measures

Name	Time	Method
Daily Average Crying and Fussing Duration According to Barr Diary Records	90 days	The parent or guardian will complete a Barr diary to measure crying and fussing times of colicky infants . It is a daily timeline that records the number of minutes in five minute increments with fussiness and crying. The average colicky infant cries and fusses is more than 3 hours daily. If infants surpasses the 3 hours for more than three days (not consecutive) and are less than 3 months of age, they are considered to have colic.

Secondary Outcome Measures

Name	Time	Method
Fecal Microbiota	90 days	Analyze and identify bacteria in the stool of the subjects. We will use pyrosequencing to characterize the bacteria colonizing the stool. We will measure diversity by Shannon's diversity index in the two groups.
Fecal Calprotectin	90 days	Test intestinal inflammation in the infants. Calprotectin is made by white blood cells called neutrophils. The number of neutrophils in the intestine is reflected by the fecal calprotectin level.

Trial Locations

Locations (1)

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States