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

Completed · Not applicable

Conditions studied: Healthy Growth

In brief

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.

Key facts

Study ID

NCT05783037

Run by

Bobbie Baby, Inc

People needed

394

Starts

2023-03-29

Expected to finish

2025-12-07

Last updated by the study team

2026-02-05

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• SPRIM Pro — Indian Harbour Beach, Florida, United States

Full record on ClinicalTrials.gov

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