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Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic (LGG)
This study has been completed.
Sponsor:
The University of Texas Health Science Center, Houston
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
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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 (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 |
Resource links provided by NLM:
Further study details as provided by J. Marc Rhoads, 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 ]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 ]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.
| 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) |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01279265
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 |
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 |
ClinicalTrials.gov processed this record on July 14, 2017