Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Crying, Intestinal Microbiota, and Intestinal Inflammation in Infants With Colic
| City: |
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Houston |
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Texas |
| Zip Code: |
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77030 |
| Conditions: |
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Healthy Infant With Colic Behavior and Fecal Characteristics |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01279265 |
| Primary Contact: |
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Principal Investigator
J. M Rhoads, M.D.
The University of Texas Health Science Center, Houston
J. M Rhoads, M.D.
Phone: 713-500-7642
Email: j.marc.rhoads@uth.tmc.edu
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| Backup Contact: |
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Email: nicole.fatheree@uth.tmc.edu
Nicole Y Fatheree, BBA
Phone: 713-500-5669
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| Location Contact: |
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Houston, Texas 77030
United States
J Marc Rhoads, M.D.
Phone: 713-500-7642
Email: j.marc.rhoads@uth.tmc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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