Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic
Public ClinicalTrials.gov record NCT01279265. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Crying, Intestinal Microbiota, and Intestinal Inflammation in Infants With Colic
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01279265
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Interventions
- Nutramigen with Enflora Dietary Supplement
- Nutramigen A+ Dietary Supplement
Dietary Supplement
Eligibility (public fields only)
- Age range
- 3 Weeks to 3 Months
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2011
- Primary completion
- Dec 31, 2012
- Completion
- Dec 31, 2012
- Last update posted
- Nov 10, 2015
2011 – 2013
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01279265, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 10, 2015 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01279265 live on ClinicalTrials.gov.