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

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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:
Information provided by (Responsible Party):

Study Description
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
Colic Inflammation Dietary Supplement: Nutramigen with Enflora Dietary Supplement: Nutramigen A+

Study Design

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
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

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

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
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
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:
Inflammation
Colic
Pathologic Processes
Infant, Newborn, Diseases