Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic
NCT ID: NCT01279265
Last Updated: 2015-11-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2011-09-30
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Nutramigen Lipil with Enflora
Formula with probiotics (Lactobaccillus Rhamnosus GG)
Nutramigen with Enflora
Hypoallergenic formula with probiotic - Lactobacillus GG
Nutramigen A+
Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG)
Nutramigen A+
Hypoallergenic formula without lactobacillus
Interventions
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Nutramigen with Enflora
Hypoallergenic formula with probiotic - Lactobacillus GG
Nutramigen A+
Hypoallergenic formula without lactobacillus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* diarrhea (stools that take the shape of a container \> 5x daily)
* fever
3 Weeks
3 Months
ALL
Yes
Sponsors
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Mead Johnson Nutrition
INDUSTRY
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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J. Marc Rhoads
Professor - Pediatrics, Gastroenterology
Principal Investigators
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J. M Rhoads, M.D.
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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References
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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.
Rhoads JM, Collins J, Fatheree NY, Hashmi SS, Taylor CM, Luo M, Hoang TK, Gleason WA, Van Arsdall MR, Navarro F, Liu Y. Infant Colic Represents Gut Inflammation and Dysbiosis. J Pediatr. 2018 Dec;203:55-61.e3. doi: 10.1016/j.jpeds.2018.07.042. Epub 2018 Aug 31.
Other Identifiers
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HSC-MS-10-0048
Identifier Type: -
Identifier Source: org_study_id
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