Growth, Tolerance, and Safety Study of Healthy Term Infan... | NCT05783037

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

NCT05783037

Sponsor

Bobbie Baby, Inc

Status

Completed

Last Update Posted

Feb 5, 2026Actual

Enrollment

394Actual

Phase

Not Applicable

Conditions

Healthy Growth

Interventions

New Organic Infant Formula
Commercial Organic Infant Formula

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 29, 2023Actual

Primary Completion Date

Dec 4, 2025Actual

Completion Date

Dec 7, 2025Actual

First Submitted Date

Mar 16, 2023

First Submission Date that Met QC Criteria

Mar 23, 2023

First Posted Date

Mar 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2026

Last Update Posted Date

Feb 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

394Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
New Organic Infant Formula	Other	New organic infant formula fed daily ad libitum	New Organic Infant Formula

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

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])

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Days

Maximum Age

11 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001835	Body Weight
D001942	Breast Feeding

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D005247	Feeding Behavior
D001519	Behavior