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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Growth
• Intervention / Treatment: Other: New Organic Infant Formula; Other: Commercial Organic Infant Formula

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

• Study Type: Interventional
• Enrollment (Estimated): 335
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Recruiting Support; Phone Number: 1-212-227-1905; Email: bobbiesupport@sprim.net

Study Locations

• United States
  • Florida
    • Indian Harbour Beach, Florida, United States, 32937
      • Recruiting
      • SPRIM Pro
      • Contact: Thomas G Lynch, MD; Phone Number: 104 212-227-1905; Email: bobbiesupport@sprim.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 week (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New Organic Infant Formula; New organic infant formula for healthy term infants	Other: New Organic Infant Formula; New organic infant formula fed daily ad libitum
Active Comparator: Commercial Organic Infant Formula; Commercially available organic infant formula for healthy term infants	Other: Commercial Organic Infant Formula; Commercially available organic infant formula fed daily ad libitum
No Intervention: Breastfed Reference Group; Breastmilk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Gain Velocity	Weight Gain Velocity (g/day)	Study Day 1 to Study Day 112

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length	Length and Length Gain Velocity (cm)	Study Day 1 to Study Day 112
Head Circumference	Head Circumference and Head Circumference Gain Velocity (cm)	Study Day 1 to Study Day 112
Formula Intake	Formula Intake Volume (oz/kg/day)	Study Day 1 to Study Day 112
Formula Intake (2)	Formula Intake Volume (oz/day)	Study Day 1 to Study Day 112
Anthropometry Z-scores	Weight for age Z-score, Length for age Z-score, Weight for length Z-score, Head circumference for age Z-score	Study Day 1 to Study Day 112

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event (AE) Assessment	AEs reported during the study	Study Day 1 to Study Day 119
Caregiver report of stool consistency obtained during 3-consecutive day intervals	0=no bowel movement, 1=hard [dry hard pellets], 2=formed [definite shape, not dry], 3=loose [no definite shape, some water], 4=watery [no shape, mainly water])	Study Day 1 to Study Day 112
Caregiver report of stool frequency obtained during 3-consecutive day intervals	Mean	Study Day 1 to Study Day 112
Caregiver report of gassiness obtained during 3-consecutive day intervals	[a] Never [b] Rarely [c] Some of the time [d] Frequently [e] Always	Study Day 1 to Study Day 112
Caregiver report of fussiness obtained during 3-consecutive day intervals	[a] Not at all [b] A little bit [c] Somewhat [d] Quite a bit [e] Very much	Study Day 1 to Study Day 112
Caregiver report of spit up obtained during 3-consecutive day intervals	Mean	Study Day 1 to Study Day 112
Caregiver report of crying obtained during 3-consecutive day intervals	Mean	Study Day 1 to Study Day 112
Caregiver report of vomiting obtained during 3-consecutive day intervals	Mean	Study Day 1 to Study Day 112
Urinalysis	Concentration of folate metabolites	Study Day 98 to Study Day 112
Formula Satisfaction	Caregiver report using sliding scale of 1=Least to 5=Most	Study Day 112

Collaborators and Investigators

• Sponsor: Bobbie Baby, Inc
• Investigators: Principal Investigator: Thomas Lynch, MD, SPRIM Pro

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Growth; Breastfeeding; Weight; Organic; Infant Formula; Bobbie; Bobbie Baby; Growth and Tolerance
• Other Study ID Numbers: BB-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No