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| Name | Class |
|---|---|
| Baylor College of Medicine | OTHER |
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The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Marketed partially hydrolyzed cow's milk protein infant formula |
|
| Investigational | Experimental | Partially hydrolyzed cow's milk infant formula with a probiotic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | Marketed partially hydrolyzed cow's milk protein infant formula |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Behavior Diary | 21 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Recall of Tolerance Questionnaire | Baseline and Day 21 | |
| Body Weight | Baseline and Day 21 | |
| Infant Behavior Questionnaire - Revised |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol Lynn Berseth, M.D. | Mead Johnson Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Nutrition Research Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36207675 | Derived | Shulman RJ, Chichlowski M, Orozco FG, Harris CL, Wampler JL, Bokulich NA, Berseth CL. Infant behavioral state and stool microbiome in infants receiving Lactocaseibacillus rhamnosus GG in formula: randomized controlled trial. BMC Pediatr. 2022 Oct 7;22(1):580. doi: 10.1186/s12887-022-03647-x. |
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| Investigational |
| Other |
Partially hydrolyzed cow's milk protein infant formula with a probiotic |
|
| Baseline and Day 21 |
| Recall of formula intake at each visit | Baseline, Day 10, and Day 18 |
| Fecal microbiome and Fecal calprotectin | Baseline and Day 21 |
| Medically-confirmed Adverse Events | 21 Days |