Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Crying, Intestinal Microbiota, and Intestinal Inflammation in Infants With Colic

Conditions
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Colic, Inflammation

Intervention / Treatment
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* Dietary Supplement: Nutramigen with Enflora
* Dietary Supplement: Nutramigen A+


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Weeks
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutramigen Lipil with Enflora<br>Formula with probiotics (Lactobaccillus Rhamnosus GG) | Dietary Supplement: Nutramigen with Enflora<br>* Hypoallergenic formula with probiotic - Lactobacillus GG<br>|
| Placebo Comparator: Nutramigen A+<br>Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG) | Dietary Supplement: Nutramigen A+<br>* Hypoallergenic formula without lactobacillus<br>* Other names: (Nutramigen Lipil);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Average Crying and Fussing Duration According to Barr Diary Records | 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. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal Microbiota | Analyze and identify bacteria in the stool of the subjects. We will use pyrosequencing to characterize the bacteria colonizing the stool. We will measure diversity by Shannon's diversity index in the two groups. | 90 days | 
| Fecal Calprotectin | Test intestinal inflammation in the infants. Calprotectin is made by white blood cells called neutrophils. The number of neutrophils in the intestine is reflected by the fecal calprotectin level. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactobacillus, Probiotic, Crying time, Fecal microbiota, Calprotectin, Colic, Infant Crying, Barr Diary, Breath Hydrogen, Clinical Design