Tolerance of Healthy Infants Fed Infant Formulas

Study Overview
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Brief Summary
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The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula.

Official Title
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Tolerance of Healthy Infants Fed Infant Formulas

Conditions
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Gastrointestinal Tolerance

Intervention / Treatment
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* Other: Phase 1- Arm 1 Infant Formula
* Other: Phase 2- Arm 2 Infant Formula
* Other: Phase 2- Arm 3 Infant Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton from a full term birth with a gestational age of 37-42 weeks. Birth weight was > 2490 g ( 5 lbs 8 oz). Age between 0 and 30 days at enrollment. Agreement to discontinue the use of medications (including over the counter [OTC], such as Mylicon® for gas), home remedies, herbal preparations or rehydration fluids that might affect GI tolerance for the duration of the study. Intention to feed the infant the study product as the sole source of nutrition for the duration of the study. Intention not to administer vitamin (other than Vitamin D) or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study. Voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study. 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 treated with antibiotics. Participation in another study that has not been approved as a concomitant study by AN.

Ages Eligible for Study
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Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1-Arm 1 Infant Formula<br>Milk-based infant formula manufactured by an alternative method. Non-commercially available formula. To be fed ad libitum. | Other: Phase 1- Arm 1 Infant Formula<br>* Powder infant formula<br>|
| Active Comparator: Phase 2- Arm 2 Infant Formula<br>Milk-based infant formula using current manufacturing and ingredients. Non-commercially available formula. To be fed ad libitum. | Other: Phase 2- Arm 2 Infant Formula<br>* Powder infant formula<br>|
| Experimental: Phase 2- Arm 3 Infant Formula<br>Milk-based infant formula using a new protein. Non-commercially available formula. To be fed ad libitum. | Other: Phase 2- Arm 3 Infant Formula<br>* Powder infant formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool consistency measured by Mean Rank Stool Consistency (MRSC) using parent reported diaries | MRSC will be calculated from data recorded on daily stool records during the study. Stool consistencies will be assigned the following: 1=watery, 2=loose/mushy, 3=soft, 4=formed, 5=hard. | Change from Study Day 1 to Study Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percentage of stools representing each stool consistency and color using parent reported diaries | Mean percentage of each recorded stool consistency (watery, loose/mushy, soft, formed, hard) and stool color (yellow, brown, green, black) will be calculated for each infant and then used to calculate for each group from daily data recorded on daily stool records during the study. | Change from Study Day 1 to Study Day 15 | 
| Mean predominant stool consistency and color measured using parent reported diaries | Mean predominant stool consistency and color for each infant calculated from data recorded on daily stool records during the study will be used to calculate the mean predominant stool consistency and color for each group. | Change from Study Day 1 to Study Day 15 | 
| Average number of stools per day measured using parent reported diaries | Average number of stools/day will be calculated for each group from data recorded on daily stool records during the study. | Change from Study Day 1 to Study Day 15 | 
| Mean percentages of feedings associated with spit-up and/or vomit measured using parent reported diaries. | Mean percentages of feedings associated with spit-up and/or vomiting will be calculated for each group from data recorded on daily formula intake records during the study. | Change from Study Day 1 to Study Day 15 | 
| Parental responses to Formula Satisfaction and Infant Feeding and Stool Patterns Questionnaires | Parental responses to individual question on the Formula Satisfaction Questionnaire will be calculated from data recorded on the questionnaire at Study Day 15 | Change from Study Day 1 to Study Day 15 | 
| Parental assessment of infant feeding and stool patterns measured by the Infant Feeding and Stool Patterns Questionnaire. | Parental responses to individual question on the Feeding and Stool Patterns Questionnaire will be calculated from data recorded on the questionnaire at Study Day 15. | Change from Study Day 1 to Study Day 15 |