Effect of Formula on Infant Behavior

Study Overview
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Brief Summary
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This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.

Official Title
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Effect of Formula Supplemented With Oligosaccharides on Infant Behavior

Conditions
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Gastrointestinal Tolerance

Intervention / Treatment
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* Other: Infant Formula supplemented with Oligosaccharides


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is in good health as determined from subject's medical history by parent report Subject is a singleton full-term birth with a gestational age of 37 - 42 weeks Subject's birth weight was ≥ 2490 g ( 5 lbs. 8 oz.) Subject is between 7 and 42 days of age Infant was identified by parents as very fussy or extremely fussy in the baseline tolerance evaluation Infant is exclusively formula-fed at time of study entry Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study Subject's parent(s) has voluntarily signed and dated an informed consent form (ICF) prior to any participation in the study Exclusion Criteria: An adverse maternal, fetal or subject medical history that has potential for effects on tolerance, growth, and/or development Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance Subject participates in another study that has not been approved as a concomitant study Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment Subject has been treated with oral antibiotics within 7 days prior to study enrollment Mother intends to use a combination of breast and formula feeding

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 42 Days

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infant Formula supplemented with Oligosaccharides<br>Ready to feed infant formula ; Feed ad libitum. | Other: Infant Formula supplemented with Oligosaccharides<br>* sole source nutrition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fussiness | Parent Questionnaires | Change from baseline (3 days prior to SD1) to within one day of initiation of study feeding (SD1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fussiness | Parent Questionnaires | Baseline to SDAY 29 | 
| Hours of daily crying | Parent Questionnaires | Baseline to SDAY 29 | 
| Gastrointestinal Tolerance | Parent Questionnaires | Baseline to SDAY 29 | 
| Stool Pattern | Parent Questionnaire | Baseline to SDAY 29 |