Behavior of Infants Fed Formula Supplemented With Prebiotics

Study Overview
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Brief Summary
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To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on symptoms of formula intolerance in healthy term infants.

Official Title
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Behavior of Infants Fed a Partially Hydrolyzed Formula Supplemented With Prebiotics

Conditions
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Gastrointestinal Tolerance

Intervention / Treatment
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* Other: Infant formula supplemented with prebiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is judged to be in good health. Subject is a singleton from a full-term birth with a gestational age of 37 - 42 weeks. Subject's birth weight was ≥ 2490 g ( 5 lbs. 8 oz.). Infant was identified by parents as very fussy or extremely fussy. Infant is exclusively formula-fed at time of study entry. Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study. 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. Exclusion Criteria: An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. Subject is taking and plans to continue medications, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect 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 prebiotics<br>infant formula powder, feed ad libitum | Other: Infant formula supplemented with prebiotics<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 study day 1) to within 1 day of initiation of study feeding | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fussiness | Parent Questionnaires | Baseline to Day 29 | 
| Hours of Daily Crying | Parent Questionnaires | Baseline to Day 29 | 
| Gastrointestinal Tolerance | Parent Questionnaires | Baseline to Day 29 | 
| Stool Pattern | Parent Questionnaires | Baseline to Day 29 |