This trial is active, not recruiting.

Condition healthy infant with colic behavior and fecal characteristics
Treatments nutramigen with enflora, nutramigen a+
Sponsor The University of Texas Health Science Center, Houston
Collaborator Mead Johnson Nutrition
Start date September 2011
End date July 2013
Trial size 60 participants
Trial identifier NCT01279265, HSC-MS-10-0048


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
(Active Comparator)
nutramigen with enflora
Hypoallergenic formula with probiotic - Lactobacillus GG
(Placebo Comparator)
Hypoallergenic formula without lactobacilli
nutramigen a+ (Nutramigen Lipil)
Hypoallergenic formula without lactobacillus

Primary Outcomes

Barr Diary
time frame: 2 years

Secondary Outcomes

Fecal Microbiota
time frame: 2 years
Fecal calprotectin
time frame: 2 years

Eligibility Criteria

Male or female participants up to 3 months old.

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

Additional Information

Official title Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Crying, Intestinal Microbiota, and Intestinal Inflammation in Infants With Colic
Principal investigator J. M Rhoads, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston.