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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: Completed NA study, sponsored by The University of Texas Health Science Center, Houston.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT01279265 record still lists
NCT01279265 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Nutramigen with Enflora is the first listed.
NCT01279265 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01279265's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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