Extensively Hydrolyzed Formula for Infant Growth

Not yet recruiting at 10 trial locations

Overseen By Amy Benson

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Mead Johnson Nutrition

Disqualifiers: Metabolic disease, Congenital malformation, Immunodeficiency, Gastrointestinal condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a research study to compare an investigational infant formula against a currently marketed infant formula. An investigational infant formula is one that has never been approved by the United States Food and Drug Administration (FDA).

The purpose of this research study is to evaluate the growth and tolerance of infants who consume a new (not yet available to buy) extensively hydrolyzed cow milk protein infant formula compared to an extensively hydrolyzed cow milk protein infant formula that is currently available to buy. The study will also look at the growth of your baby, how many poops your baby has, what the poops are like (for example, soft or hard), how much study formula your baby drinks, how well your baby handles the study formula (such as spit-up, fussiness, gas, colic, or changes in sleep), and any health problems that might come up during the study.

Who Is on the Research Team?

Veronica Fabrizio, DO

Principal Investigator

Mead Johnson Nutrition

Are You a Good Fit for This Trial?

Inclusion Criteria

Gestational age of 37 weeks + 0 days to 41 weeks + 6 days, inclusive

Parent(s) or legal guardian(s) have full intention to exclusively feed their infant study formula through 126 days of age

Decentralized participant's parent/caregiver or legal guardian anticipates having a second adult available for all remote visits

Exclusion Criteria

History of underlying metabolic or chronic disease; congenital malformation; immunodeficiency, gastrointestinal condition, or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food by mouth, the normal growth and development of the infant, or the evaluation of the infant

Evidence of feeding difficulties or history of formula intolerance, such as vomiting or poor intake at time of randomization

First degree relative (if known) history of cow's milk protein intolerance or allergy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants consume either the investigational or control extensively hydrolyzed casein formula

16 weeks

Regular monitoring visits

Follow-up

Participants are monitored for growth and tolerance outcomes after treatment

up to 5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Extensively hydrolyzed casein formula (INV-eHCF)

How Is the Trial Designed?

Group I: Extensively hydrolyzed casein formula (INV-eHCF) Experimental Treatment 1 Intervention

Group II: Extensively hydrolyzed casein formula (C-eHCF), commercially available Active Control 1 Intervention

Who Is Running the Clinical Trial?

Mead Johnson Nutrition

Lead Sponsor

Trials

80

Recruited

15,900+