Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic (LGG)

This study has been completed.
Sponsor:
Collaborator:
Mead Johnson Nutrition
Information provided by (Responsible Party):
J. Marc Rhoads, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01279265
First received: January 12, 2011
Last updated: October 7, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention
Colic
Inflammation
Dietary Supplement: Nutramigen with Enflora
Dietary Supplement: Nutramigen A+

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Crying, Intestinal Microbiota, and Intestinal Inflammation in Infants With Colic

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Daily Average Crying and Fussing Duration According to Barr Diary Records [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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:
  • Fecal Microbiota [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nutramigen Lipil with Enflora
Formula with probiotics (Lactobaccillus Rhamnosus GG)
Dietary Supplement: Nutramigen with Enflora
Hypoallergenic formula with probiotic - Lactobacillus GG
Placebo Comparator: Nutramigen A+
Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG)
Dietary Supplement: Nutramigen A+
Hypoallergenic formula without lactobacillus
Other Name: (Nutramigen Lipil)

  Eligibility

Ages Eligible for Study:   up to 3 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279265

Locations
United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Mead Johnson Nutrition
Investigators
Principal Investigator: J. M Rhoads, M.D. The University of Texas Health Science Center, Houston
  More Information

Publications:
Responsible Party: J. Marc Rhoads, Professor - Pediatrics, Gastroenterology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01279265     History of Changes
Other Study ID Numbers: HSC-MS-10-0048 
Study First Received: January 12, 2011
Results First Received: June 11, 2015
Last Updated: October 7, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Lactobacillus
Probiotic
Crying time
Fecal microbiota
Calprotectin
Colic
Infant Crying
Barr Diary
Breath Hydrogen
Clinical Design

Additional relevant MeSH terms:
Inflammation
Colic
Pathologic Processes
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on August 28, 2016