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| Name | Class |
|---|---|
| Mead Johnson Nutrition | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutramigen Lipil with Enflora | Active Comparator | Formula with probiotics (Lactobaccillus Rhamnosus GG) |
|
| Nutramigen A+ | Placebo Comparator | Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutramigen with Enflora | Dietary Supplement | Hypoallergenic formula with probiotic - Lactobacillus GG |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. M Rhoads, M.D. | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19628216 | Background | Rhoads JM, Fatheree NY, Norori J, Liu Y, Lucke JF, Tyson JE, Ferris MJ. Altered fecal microflora and increased fecal calprotectin in infants with colic. J Pediatr. 2009 Dec;155(6):823-828.e1. doi: 10.1016/j.jpeds.2009.05.012. Epub 2009 Jul 22. | |
| 30177353 | Derived | Rhoads JM, Collins J, Fatheree NY, Hashmi SS, Taylor CM, Luo M, Hoang TK, Gleason WA, Van Arsdall MR, Navarro F, Liu Y. Infant Colic Represents Gut Inflammation and Dysbiosis. J Pediatr. 2018 Dec;203:55-61.e3. doi: 10.1016/j.jpeds.2018.07.042. Epub 2018 Aug 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nutramigen Lipil With Enflora | Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG |
| FG001 | Nutramigen A+ | Hypoallergenic formula without lactobacilli Nutramigen A+: Hypoallergenic formula without lactobacillus |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nutramigen Lipil With Enflora | Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG |
| BG001 | Nutramigen A+ | Hypoallergenic formula without lactobacilli Nutramigen A+: Hypoallergenic formula without lactobacillus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | minutes | 90 days |
|
90 days (3 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nutramigen Lipil With Enflora | Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG |
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75% of eligible babies either declined to enter the study or dropped out.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. J. Marc Rhoads, Director, Pediatric Gastroenterology | University of Texas Health Science Center at Houston | 713-500-7642 | j.marc.rhoads@uth.tmc.edu |
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| ID | Term |
|---|---|
| D003085 | Colic |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C097269 | pregestimil |
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| Nutramigen A+ | Dietary Supplement | Hypoallergenic formula without lactobacillus |
|
|
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Hypoallergenic formula without lactobacilli
Nutramigen A+: Hypoallergenic formula without lactobacillus
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| Secondary | 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. | Posted | Mean | Standard Deviation | Shannon's diversity index value | 90 days |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | µg/g (feces) | 90 days |
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| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Nutramigen A+ | Hypoallergenic formula without lactobacilli Nutramigen A+: Hypoallergenic formula without lactobacillus | 0 | 11 | 0 | 11 |
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| Visit 3 - Day 42 |
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| Visit 4 - Day 90 |
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| Visit 3 - Day 42 |
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| Visit 4 - Day 90 |
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