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NCT01279265 · ClinicalTrials.gov registry record · NA
Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic
A NA study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT01279265 is a NA study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 30 participants.
The verdict
NCT01279265, a NA study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DIETARY_SUPPLEMENT Nutramigen with Enflora
- DIETARY_SUPPLEMENT Nutramigen A+
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01279265
The ClinicalTrials.gov registry entry for NCT01279265 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nutramigen with Enflora is the first listed.
NCT01279265 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01279265 about?
NCT01279265 is a clinical study titled "Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic". 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 babie...
What is the current status of trial NCT01279265?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2011-09. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01279265?
The interventions under investigation include: Nutramigen with Enflora (DIETARY_SUPPLEMENT), Nutramigen A+ (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01279265?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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