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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colic Inflammation Dietary Supplement: Nutramigen with Enflora Dietary Supplement: Nutramigen A+ Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Crying, Intestinal Microbiota, and Intestinal Inflammation in Infants With Colic
Study Start Date : September 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279265


Locations
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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
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Principal Investigator: J. M Rhoads, M.D. The University of Texas Health Science Center, Houston
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: J. Marc Rhoads, Professor - Pediatrics, Gastroenterology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01279265    
Other Study ID Numbers: HSC-MS-10-0048
First Posted: January 19, 2011    Key Record Dates
Results First Posted: November 11, 2015
Last Update Posted: November 11, 2015
Last Verified: October 2015
Keywords provided by J. Marc Rhoads, 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:
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Colic
Inflammation
Pathologic Processes
Infant, Newborn, Diseases