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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-29

Study Completion Date

2025-11-30

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.

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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

Conditions

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Healthy Growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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New Organic Infant Formula

New organic infant formula for healthy term infants

Group Type EXPERIMENTAL

New Organic Infant Formula

Intervention Type OTHER

New organic infant formula fed daily ad libitum

Commercial Organic Infant Formula

Commercially available organic infant formula for healthy term infants

Group Type ACTIVE_COMPARATOR

Commercial Organic Infant Formula

Intervention Type OTHER

Commercially available organic infant formula fed daily ad libitum

Breastfed Reference Group

Breastmilk

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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New Organic Infant Formula

New organic infant formula fed daily ad libitum

Intervention Type OTHER

Commercial Organic Infant Formula

Commercially available organic infant formula fed daily ad libitum

Intervention Type OTHER

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 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

Minimum Eligible Age

0 Days

Maximum Eligible Age

11 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes