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

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.
 
ClinicalTrials.gov Identifier: NCT01279265
Recruitment Status : Completed
First Posted : January 19, 2011
Results First Posted : November 11, 2015
Last Update Posted : November 11, 2015
Sponsor:
Collaborator:
Mead Johnson Nutrition
Information provided by (Responsible Party):
J. Marc Rhoads, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE January 12, 2011
First Posted Date  ICMJE January 19, 2011
Results First Submitted Date  ICMJE June 11, 2015
Results First Posted Date  ICMJE November 11, 2015
Last Update Posted Date November 11, 2015
Study Start Date  ICMJE September 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2011)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2011)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic
Official Title  ICMJE Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Crying, Intestinal Microbiota, and Intestinal Inflammation in Infants With Colic
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Colic
  • Inflammation
Intervention  ICMJE
  • Dietary Supplement: Nutramigen with Enflora
    Hypoallergenic formula with probiotic - Lactobacillus GG
  • Dietary Supplement: Nutramigen A+
    Hypoallergenic formula without lactobacillus
    Other Name: (Nutramigen Lipil)
Study Arms  ICMJE
  • 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+
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2015)
30
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2011)
45
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Weeks to 3 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01279265
Other Study ID Numbers  ICMJE HSC-MS-10-0048
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party J. Marc Rhoads, The University of Texas Health Science Center, Houston
Original Responsible Party J. Marc Rhoads, MD, University of Texas Medical School at Houston, Department of Pediatrics, Division of Gastroenterology
Current Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Mead Johnson Nutrition
Investigators  ICMJE
Principal Investigator: J. M Rhoads, M.D. The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date October 2015

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