Tolerance of Healthy Term Infants Fed Infant Formulas #3

Study Overview
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Brief Summary
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The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.

Official Title
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Tolerance of Healthy Term Infants Fed Infant Formulas

Conditions
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Gastrointestinal Tolerance

Intervention / Treatment
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* Other: Experimental milk protein infant formula Process A
* Other: Experimental milk protein infant formula Process B
* Other: Experimental milk protein infant formula Process C
* Other: Experimental milk protein infant formula Process D
* Other: Experimental milk protein infant formula Process E
* Other: Experimental milk protein infant formula Process F


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infant is judged to be in good health. Infant is a singleton from a full term birth. Infant's birth weight was > 2490 g ( 5 lbs 8 oz. Infant is between 0 and 8 days of age at enrollment. Infants using medications, home remedies ,herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled. 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, unless instructed otherwise by their healthcare professional. Exclusion Criteria: An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. Infant has been treated with antibiotics. Infant has received probiotics.

Ages Eligible for Study
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Maximum Age: 8 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milk Based Protein Formula Process A<br> | Other: Experimental milk protein infant formula Process A<br>* ad lib for 1-8 days of age until 28 days of age<br>|
| Experimental: Milk Based Protein Formula Process B<br> | Other: Experimental milk protein infant formula Process B<br>* ad lib from 1-8 days of age until 28 days of age<br>|
| Experimental: Milk Based Protein Formula Process C<br> | Other: Experimental milk protein infant formula Process C<br>* ad lib from 1-8 days of age to 28 days of age<br>|
| Experimental: Milk Based Protein Formula Process D<br> | Other: Experimental milk protein infant formula Process D<br>* ad lib from 1-8 days of age until 28 days of age<br>|
| Experimental: Milk Based Protein Formula Process E<br> | Other: Experimental milk protein infant formula Process E<br>* ad lib from 1-8 days of age until 28 days of age<br>|
| Experimental: Milk Based Protein Formula Process F<br> | Other: Experimental milk protein infant formula Process F<br>* ad lib from 1-8 days of age until 28 days of age<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary variable is Gastrointestinal tolerance. |  | 1-28 days of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary variables are additional measures of GI tolerance and parental feedback. |  | 1-28 days of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant