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

NCT05783037 | Completed

• 1 other identifier: BB-01
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Growth

Keywords

Organic; Bobbie; Bobbie Baby; Weight; Growth; Breastfeeding; Infant Formula; Growth and Tolerance

Outcome Measures

Primary Outcomes (1)

• Weight Gain Velocity

  Weight Gain Velocity (g/day)

  Study Day 1 to Study Day 112

Secondary Outcomes (5)

• Length

  Study Day 1 to Study Day 112

• Head Circumference

  Study Day 1 to Study Day 112

• Formula Intake

  Study Day 1 to Study Day 112

• Formula Intake (2)

  Study Day 1 to Study Day 112

• Anthropometry Z-scores

  Study Day 1 to Study Day 112

Other Outcomes (10)

• Adverse Event (AE) Assessment

  Study Day 1 to Study Day 119

• Caregiver report of stool consistency obtained during 3-consecutive day intervals

  Study Day 1 to Study Day 112

• Caregiver report of stool frequency obtained during 3-consecutive day intervals

  Study Day 1 to Study Day 112

Study Arms (3)

New Organic Infant Formula

EXPERIMENTAL

New organic infant formula for healthy term infants

Other: New Organic Infant Formula

Commercial Organic Infant Formula

ACTIVE COMPARATOR

Commercially available organic infant formula for healthy term infants

Other: Commercial Organic Infant Formula

Breastfed Reference Group

NO INTERVENTION

Breastmilk

Interventions

Commercial Organic Infant Formula OTHER

Commercially available organic infant formula fed daily ad libitum

Commercial Organic Infant Formula

New Organic Infant Formula OTHER

New organic infant formula fed daily ad libitum

New Organic Infant Formula

Eligibility Criteria

• Age: 0 Days - 11 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Bobbie Baby, Inc: lead

Study Sites (1)

SPRIM Pro

Indian Harbour Beach, Florida, 32937, United States

Location

MeSH Terms

Conditions

Body Weight; Breast Feeding

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Thomas Lynch, MD

  SPRIM Pro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 24, 2023
• Study Start: March 29, 2023
• Primary Completion: December 4, 2025
• Study Completion: December 7, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)