N/A
N=30
Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic
Colic · Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT01279265 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Daily Average Crying and Fussing Duration According to Barr Diary Records — 111; 133 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nutramigen with Enflora (Dietary_supplement); Nutramigen A+ (Dietary_supplement)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Average Crying and Fussing Duration According to Barr Diary Records |
111; 133 | — |
| SECONDARY Fecal Microbiota |
.946; .991; 1.314; .537; 1.047; 1.161 | — |
| SECONDARY Fecal Calprotectin |
285; 294; 226; 305; 229; 250 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01279265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.