Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming an Organic Cow's Milk-Based Infant Formula

Study Overview
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Brief Summary
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The goal of this study is to demonstrate that healthy term babies who are fed Bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula. Breastfeeding is the ultimate reference for infant nutrition. Therefore, this study also includes a group of breastfed babies for additional comparison.

Detailed Description
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This is a 16 week, double-blind, randomized, controlled trial designed to demonstrate that a new infant formula for term infants supports age-appropriate growth. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96

Official Title
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Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming an Organic Cow's Milk-Based Infant Formula

Conditions
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Healthy Growth

Intervention / Treatment
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* Other: New Organic Infant Formula
* Other: Commercial Organic Infant Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days) Birth weight of ≥ 2,500 g and ≤ 4,500 g Postnatal age ≤ 11 days at time of enrollment Singleton Caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding) Caregiver willing to conform to protocol requirements (e.g. measuring, feeding, completion of food intake and tolerance diaries, reporting of AEs, and urine collection) Caregiver willing and able to sign IRB approved informed consent Exclusion Criteria: Infant born with medical complications (e.g., neurological, cerebral palsy, etc.) Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth Maternal, fetal, or infant medical history thought to have an impact on growth and/or development (substance abuse, positive HIV status, opioid exposure, or diabetes requiring insulin) Infant receiving prescription medication Infant or family (parent/sibling) with a known history of cow's milk protein allergy, excluding lactose intolerance Infant who has been treated with antibiotics or medications that may impact growth, GI tolerance and/or development Infant or family history (grandparent, parent, sibling) with known folate metabolism disorder Caregiver intent to feed non-study formula or solid food during the study

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 11 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Organic Infant Formula<br>New organic infant formula for healthy term infants | Other: New Organic Infant Formula<br>* New organic infant formula fed daily ad libitum<br>|
| Active Comparator: Commercial Organic Infant Formula<br>Commercially available organic infant formula for healthy term infants | Other: Commercial Organic Infant Formula<br>* Commercially available organic infant formula fed daily ad libitum<br>|
| No Intervention: Breastfed Reference Group<br>Breastmilk | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Gain Velocity | Weight Gain Velocity (g/day) | Study Day 1 to Study Day 112 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length | Length and Length Gain Velocity (cm) | Study Day 1 to Study Day 112 | 
| Head Circumference | Head Circumference and Head Circumference Gain Velocity (cm) | Study Day 1 to Study Day 112 | 
| Formula Intake | Formula Intake Volume (oz/kg/day) | Study Day 1 to Study Day 112 | 
| Formula Intake (2) | Formula Intake Volume (oz/day) | Study Day 1 to Study Day 112 | 
| Anthropometry Z-scores | Weight for age Z-score, Length for age Z-score, Weight for length Z-score, Head circumference for age Z-score | Study Day 1 to Study Day 112 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight, Organic, Bobbie, Bobbie Baby, Growth, Breastfeeding, Infant Formula, Growth and Tolerance