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The purpose of this study is to evaluate the stool composition and GI tolerance of an experimental formula with a new fat blend plus L. reuteri vs control formula.
Double-blind, randomized, controlled clinical trial. The purpose of this study is to evaluate the stool composition and GI tolerance of 140 healthy, term infants fed with an infant formula with a new fat blend plus L. reuteri vs a standard infant formula. All enrolled infants will participate in the trial for approximately 71 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Infant Formula | Experimental | Experimental Infant Formula with a new fat blend plus L. reuteri |
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| Standard Infant Formula | Active Comparator | Standard bovine milk-based infant formula. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Infant Formula | Other | Standard bovine milk-based infant formula with a new fat blend plus L. reuteri, fed ad libitum |
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| Measure | Description | Time Frame |
|---|---|---|
| Stool Consistency Score | 3-day Gastrointestinal (GI) Symptom and Behavior Diary, a parent-reported symptom diary to record stool consistency and stool frequency over the 3 consecutive days. A validated 5-point pictorial representation of the consistency of the stool for infants ≤1 year (1=watery, 2=runny, 3=mushy soft, 4=formed, 5=hard) will be provided in the stool diary for parent(s)/LAR to visually assess the infants' stools. Stool consistency will be compared between formula groups The baseline stool consistency value will also be included in the model as a covariate. the percentage of stools in each category (watery, runny, mushy soft, formed, or hard) will be calculated by visit for each infant and then will be summarized using the appropriate descriptive statistics. Figures composed of a series of histograms will be produced for each 3-day stool diary period. | Study Day 57, corresponding to infant age of 78-85 days |
| Measure | Description | Time Frame |
|---|---|---|
| GI Tolerance | Infant Gastrointestinal Symptom Questionnaire (IGSQ) Overall GI symptom burden will be measured with the IGSQ-13 questionnaire. The IGSQ-13 is an interviewer-administered questionnaire which measures how well the infant tolerates his/her feedings from the parent's/caregiver's perspective. The questionnaire is composed of 13 questions, categorized into 5 symptom domains of stooling, vomiting/spitting-up, crying, fuzziness, and flatulence and summed to calculate an index score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elvira M Estorninos | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Hospital and Medical Center | City of Muntinlupa | 1781 | Philippines |
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| Standard Infant Formula | Other | Standard bovine milk-based infant formula, fed ad libitum |
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| which corresponds to infant age of 21-28, 43-50, and 78-85 days. |
| Changes in Weight from baseline to 57 days | weight (kg) | Study Day 57, corresponding to infant age of 78-85 days |
| Changes in Length from baseline to 57 days | length (cm) | Study Day 57, corresponding to infant age of 78-85 days |
| Changes in Head Circumference from baseline to 57 days | head circumference (cm) | Study Day 57, corresponding to infant age of 78-85 days |