Clinical trial NCT05783037: Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming a New Organic Cow's Milk-Based Infant Formula
Official title: Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming a New Organic Cow's Milk-Based Infant Formula
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Growth
Keywords: Organic
Bobbie
Bobbie Baby
Weight
Growth
Breastfeeding
Infant Formula
Growth and Tolerance
Lead sponsor: Bobbie Baby, Inc
Sponsor class: INDUSTRY
First posted: 2023-03-24
Enrollment: 335
Sex: ALL
Minimum age (years): 0
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks
Primary purpose: OTHER

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Weight Gain Velocity
timeFrame: Study Day 1 to Study Day 112
Secondary outcomes:
measure: Length
timeFrame: Study Day 1 to Study Day 112
measure: Head Circumference
timeFrame: Study Day 1 to Study Day 112
measure: Formula Intake
timeFrame: Study Day 1 to Study Day 112
measure: Formula Intake (2)
timeFrame: Study Day 1 to Study Day 112
measure: Anthropometry Z-scores
timeFrame: Study Day 1 to Study Day 112
Other outcomes:
measure: Adverse Event (AE) Assessment
timeFrame: Study Day 1 to Study Day 119
measure: Caregiver report of stool consistency obtained during 3-consecutive day intervals
timeFrame: Study Day 1 to Study Day 112
measure: Caregiver report of stool frequency obtained during 3-consecutive day intervals
timeFrame: Study Day 1 to Study Day 112
measure: Caregiver report of gassiness obtained during 3-consecutive day intervals
timeFrame: Study Day 1 to Study Day 112
measure: Caregiver report of fussiness obtained during 3-consecutive day intervals
timeFrame: Study Day 1 to Study Day 112
measure: Caregiver report of spit up obtained during 3-consecutive day intervals
timeFrame: Study Day 1 to Study Day 112
measure: Caregiver report of crying obtained during 3-consecutive day intervals
timeFrame: Study Day 1 to Study Day 112
measure: Caregiver report of vomiting obtained during 3-consecutive day intervals
timeFrame: Study Day 1 to Study Day 112
measure: Urinalysis
timeFrame: Study Day 98 to Study Day 112
measure: Formula Satisfaction
timeFrame: Study Day 112
Locations:
city: Indian Harbour Beach
country: United States
facility: SPRIM Pro
state: Florida
Study officials:
affiliation: SPRIM Pro
name: Thomas Lynch, MD
role: PRINCIPAL_INVESTIGATOR
References: