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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01279265
First Posted: January 19, 2011
Last Update Posted: November 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mead Johnson Nutrition
Information provided by (Responsible Party):
J. Marc Rhoads, The University of Texas Health Science Center, Houston
January 12, 2011
January 19, 2011
June 11, 2015
November 11, 2015
November 11, 2015
September 2011
January 2013   (Final data collection date for primary outcome measure)
Daily Average Crying and Fussing Duration According to Barr Diary Records [ Time Frame: 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.
Barr Diary [ Time Frame: 2 years ]
This will measure crying times of infants. It is a daily timeline that records the number of minutes with fussiness and crying. Normal is less than 3 hours of crying + fussing time daily.
Complete list of historical versions of study NCT01279265 on ClinicalTrials.gov Archive Site
  • Fecal Microbiota [ Time Frame: 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 [ Time Frame: 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.
  • Fecal Microbiota [ Time Frame: 2 years ]
    Analyze and identify bacteria in the stool of the subjects. We will use pyrosequencing to characterize the bacteria colonizing the stool. We will measure if the probiotic is retained 3 months after stopping the Lactobacillus GG-containing formula.
  • Fecal Calprotectin [ Time Frame: 2 years ]
    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.
Not Provided
Not Provided
 
Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic
Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Crying, Intestinal Microbiota, and Intestinal Inflammation in Infants With Colic
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
  • Colic
  • Inflammation
  • Dietary Supplement: Nutramigen with Enflora
    Hypoallergenic formula with probiotic - Lactobacillus GG
  • Dietary Supplement: Nutramigen A+
    Hypoallergenic formula without lactobacillus
    Other Name: (Nutramigen Lipil)
  • Active Comparator: Nutramigen Lipil with Enflora
    Formula with probiotics (Lactobaccillus Rhamnosus GG)
    Intervention: Dietary Supplement: Nutramigen with Enflora
  • Placebo Comparator: Nutramigen A+
    Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG)
    Intervention: Dietary Supplement: Nutramigen A+
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2013
January 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 3 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01279265
HSC-MS-10-0048
Yes
Not Provided
Not Provided
J. Marc Rhoads, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Mead Johnson Nutrition
Principal Investigator: J. M Rhoads, M.D. The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP