New Infant Formula for Weight Gain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
ObvioHealth, New York, NY
Weight Gain
New Infant Formula - Other
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

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.

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 16 weeks

16 weeks
Assessment of AEs
Caregiver report of stool characteristics obtained during 3-consecutive day intervals
Caregiver report of tolerance obtained during 3-consecutive day intervals
Head Circumference gain from baseline to 16 weeks feeding
Length gain from baseline to 16 weeks feeding
Stool collection for microbiome testing
Volume of formula consumed during 3-consecutive day intervals
Weight gain from baseline to 16 weeks feeding

Trial Safety

Trial Design

5 Treatment Groups

Cow Milk Formula
1 of 5
Commercial Infant Formula
1 of 5
Human Milk
1 of 5
Goat Milk Formula
1 of 5
New Infant Formula
1 of 5
Active Control
Experimental Treatment

240 Total Participants · 5 Treatment Groups

Primary Treatment: New Infant Formula · No Placebo Group · N/A

Goat Milk Formula
Other
Experimental Group · 1 Intervention: Goat Milk Formula · Intervention Types: Other
New Infant Formula
Other
Experimental Group · 1 Intervention: New Infant Formula · Intervention Types: Other
Cow Milk Formula
Other
ActiveComparator Group · 1 Intervention: Cow Milk Formula · Intervention Types: Other
Commercial Infant Formula
Other
ActiveComparator Group · 1 Intervention: Commercial Infant Formula · Intervention Types: Other
Human MilkNoIntervention Group · 1 Intervention: Human Milk · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks
Closest Location: ObvioHealth · New York, NY
Photo of New York 1Photo of New York 2Photo of New York 3
2018First Recorded Clinical Trial
1 TrialsResearching Weight Gain
5 CompletedClinical Trials

Who is running the clinical trial?

Jovie USA, LLCLead Sponsor
ObvioHealthIndustry Sponsor
8 Previous Clinical Trials
9,186 Total Patients Enrolled
IQVIA RDS Inc.UNKNOWN
2 Previous Clinical Trials
13,178 Total Patients Enrolled
Dawn Ross, Director Clinical Project ManagementStudy DirectorIQVIA RDS Inc.
Parth Shah, MD FAPCRPrincipal InvestigatorObvioHealth

Eligibility Criteria

Age < 18 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to conform to protocol requirements.
You are a baby born weighing at least 2500 g (5.5 lbs.
You are a healthy infant.
You are a 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).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.