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

Bobbie Baby

Status: Enrolling

Conditions: Healthy Growth

Treatments: Other: Commercial Organic Infant Formula; Other: New Organic Infant Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT05783037

BB-01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 335 estimated patients

Sex: All

Ages: Under 11 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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335 participants in 3 patient groups

New Organic Infant Formula

Experimental group

Description:

New organic infant formula for healthy term infants

Treatment:

Other: New Organic Infant Formula

Commercial Organic Infant Formula

Active Comparator group

Description:

Commercially available organic infant formula for healthy term infants

Treatment:

Other: Commercial Organic Infant Formula

Breastfed Reference Group

No Intervention group

Description:

Breastmilk