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

Description

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.

Conditions

Healthy Growth

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Healthy Growth
Intervention / Treatment

-

Contacts and Locations

Indian Harbour Beach

SPRIM Pro, Indian Harbour Beach, Florida, United States, 32937

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

0 Days to 11 Days

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Bobbie Baby, Inc,

Thomas Lynch, MD, PRINCIPAL_INVESTIGATOR, SPRIM Pro

Study Record Dates

2024-12