Formula Tolerance of Term Infants

Study Overview
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Brief Summary
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To assess the effects of infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants

Official Title
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Tolerance of Term Infants Fed Formula With Oligosaccharides

Conditions
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Gastro-Intestinal Tolerance

Intervention / Treatment
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* Other: Study Infant Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is judged to be in good health as determined from participant's medical history by parent report Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks. Participant's birth weight was >= 2490 g ( 5 lbs. 8 oz.) Participant was identified by parents as very fussy or extremely fussy in the Baseline Tolerance Evaluation on a formula-feed Participant is exclusively formula-fed at time of study entry and Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional. Parent(s) confirm their intention not to administer vitamin, mineral, human milk oligosaccharide(s) (HMO), prebiotic(s), or probiotic(s) supplements (with the exception of vitamin D supplements if instructed by their healthcare professional), non-study formula, foods, juices, or other sources of nutrition to their infant from enrollment through the duration of the study Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided applicable local privacy regulation authorization prior to any participation in the study Exclusion Criteria: An adverse maternal, fetal, or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. This includes but is not limited to suspected maternal substance abuse. Participant is taking and plans to continue taking medications (including OTC, such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, or rehydration fluids that might affect GI tolerance. Participant participates in another study that has not been approved as a concomitant study Participant has been fed a formula with greater than 2 HMOs prior to study enrollment Participant has been fed an extensively hydrolyzed, amino acid based, or preterm formula within 14 days prior to study enrollment and/or an extensively hydrolyzed, amino acid based, or preterm formula has been recommended by the physician. Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent Participant has been treated with antibiotics within 7 days prior to enrollment

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 65 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: Study Infant Formula<br>Feed ad libitum during study period | Other: Study Infant Formula<br>* RTF milk-based infant formula with oligosaccharides<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fussiness | Absolute and % change in fussiness severity reported from Daily Tolerance Diary | Baseline to Study Day (SDAY) 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Tolerance | Parent Completed Diary | Baseline to SDAY 28 | 
| Stool | Parent Completed Diary | Baseline to SDAY 28 |