Growth and Safety Clinical Trial on a New Infant Formula

A Randomized, Controlled Trial Evaluating Growth and Safety in Infants Fed a New Infant Formula

The aim of this study is to assess age-appropriate growth of healthy infants fed a new infant formula. In this randomized, controlled trial, healthy, term, formula-fed infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants or the new infant formula for term infants for 16 weeks. A reference group of human milk-fed infants will also be enrolled. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. This study allows caregivers to participate completely from the comfort of their own home.

Study Overview

• Status: Completed
• Conditions: Weight Gain
• Intervention / Treatment: Other: New Infant Formula; Other: Commercial Infant Formula

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan van Marwijk, CEO Jovie USA LLC; Phone Number: +1 847-337-2615; Email: j.vanmarwijk@jovieusa.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • ObvioHealth

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Normal term infant (37-42 weeks gestation at birth)
• Infant <15 (+3) days of age at first study feeding, Birth constitutes day 0
• Infant birth weight of ≥2500 g (5.5 lbs.)
• Healthy Infant
• 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, and reporting of AEs)
• Caregiver willing and able to sign informed consent

Exclusion Criteria:

• Infant born in multiple birth (i.e., twins, triplets, etc.)
• Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
• Infant with family history (parents or siblings) of confirmed Milk or Soy allergies
• 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
• 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: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New Infant Formula; New infant formula for healthy term infants	Other: New Infant Formula; New infant formula fed daily ad libitum
Active Comparator: Commercial Infant Formula; Standard, commercially available infant formula for healthy term infants	Other: Commercial Infant Formula; Commercially available infant formula fed daily ad libitum
No Intervention: Human Milk; Breastfed infants serve as a reference group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight gain from baseline to 16 weeks feeding	Weight gain g/day	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length gain from baseline to 16 weeks feeding	Length gain	16 weeks
Head Circumference gain from baseline to 16 weeks feeding	Head Circumference gain	16 weeks
Volume of formula consumed during 3-consecutive day intervals	Volume of formula consumed	16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of AEs	AEs reported during the study	16 weeks
Caregiver report of tolerance obtained during 3-consecutive day intervals	Caregiver report of fussiness, gassiness, and spitting up	16 weeks
Caregiver report of stool characteristics obtained during 3-consecutive day intervals	Caregiver report of stool consistency, color, and frequency	16 weeks
Stool collection for microbiome testing	Stool collection for microbiome testing at week 16 of feeding	16 weeks

Collaborators and Investigators

• Sponsor: Jovie USA, LLC
• Collaborators: IQVIA RDS Inc.; ObvioHealth
• Investigators: Principal Investigator: Parth Shah, MD FAPCR, ObvioHealth; Study Director: Dawn Ross, Director Clinical Project Management, IQVIA RDS Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): January 2, 2024
• Study Completion (Actual): January 2, 2024

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: infant; formula; in-home
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain
• Other Study ID Numbers: IQV-JOV-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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