Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic

Inflammation Clinical Trial

— LGG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279265
• Other study ID #: HSC-MS-10-0048
• Status: Completed
• Phase: N/A
• First received: January 12, 2011
• Last updated: October 7, 2015
• Start date: September 2011
• Est. completion date: January 2013

Study information

• Verified date: October 2015
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colic
• Inflammation

Intervention

Dietary Supplement:
• Nutramigen with Enflora
Hypoallergenic formula with probiotic - Lactobacillus GG
• Nutramigen A+
Hypoallergenic formula without lactobacillus

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rhoads JM, Fatheree NY, Norori J, Liu Y, Lucke JF, Tyson JE, Ferris MJ. Altered fecal microflora and increased fecal calprotectin in infants with colic. J Pediatr. 2009 Dec;155(6):823-828.e1. doi: 10.1016/j.jpeds.2009.05.012. Epub 2009 Jul 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Average Crying and Fussing Duration According to Barr Diary Records	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.	90 days	No
Secondary	Fecal Microbiota	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.	90 days	No
Secondary	Fecal Calprotectin	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.	90 days	No