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

Healthy Growth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783037
• Other study ID #: BB-01
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Bobbie Baby, Inc
• Contact: Recruiting Support
• Phone: 1-212-227-1905
• Email: bobbiesupport[@]sprim.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 335
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Days to 11 Days

Eligibility

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

Related Conditions & MeSH terms

• Healthy Growth

Intervention

Other:
• New Organic Infant Formula
New organic infant formula fed daily ad libitum
• Commercial Organic Infant Formula
Commercially available organic infant formula fed daily ad libitum

Locations

Country	Name	City	State
United States	SPRIM Pro	Indian Harbour Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bobbie Baby, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Event (AE) Assessment	AEs reported during the study	Study Day 1 to Study Day 119
Other	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
Other	Caregiver report of stool frequency obtained during 3-consecutive day intervals	Mean	Study Day 1 to Study Day 112
Other	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
Other	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
Other	Caregiver report of spit up obtained during 3-consecutive day intervals	Mean	Study Day 1 to Study Day 112
Other	Caregiver report of crying obtained during 3-consecutive day intervals	Mean	Study Day 1 to Study Day 112
Other	Caregiver report of vomiting obtained during 3-consecutive day intervals	Mean	Study Day 1 to Study Day 112
Other	Urinalysis	Concentration of folate metabolites	Study Day 98 to Study Day 112
Other	Formula Satisfaction	Caregiver report using sliding scale of 1=Least to 5=Most	Study Day 112
Primary	Weight Gain Velocity	Weight Gain Velocity (g/day)	Study Day 1 to Study Day 112
Secondary	Length	Length and Length Gain Velocity (cm)	Study Day 1 to Study Day 112
Secondary	Head Circumference	Head Circumference and Head Circumference Gain Velocity (cm)	Study Day 1 to Study Day 112
Secondary	Formula Intake	Formula Intake Volume (oz/kg/day)	Study Day 1 to Study Day 112
Secondary	Formula Intake (2)	Formula Intake Volume (oz/day)	Study Day 1 to Study Day 112
Secondary	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