Growth
Conditions
Brief summary
This study is a non-inferiority, decentralized, randomized, double-blind, controlled clinical trial evaluating the growth, tolerance, and safety of a goat's-milk test infant formula (Test Formula 1; TF1) and a cow's-milk test infant formula (Test Formula 2; TF2), each compared to a cow's-milk infant formula commercially available in the United States (Control Formula; CF).
Interventions
OTHERAdvance Infant Formula Powder
Sole source infant nutrition for the control arm.
OTHER"Kendamil Cow milk test product
Sole source infant nutrition for the cow milk test arm.
OTHER"Kendamil goat milk test product
Sole source infant nutrition for the goat milk test arm.
Sponsors
Kendal Nutricare Ltd
ObvioHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
RP Over stickered TP in blank packaging.
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Days
Healthy volunteers
Yes
Inclusion criteria
1. Healthy term infants (37 to 42 weeks gestation at birth) from a singleton birth as assessed by the investigator 2. Infants with a birth weight of \>2500 g to \<4500 g 3. Infants ≤11 days of age at enrollment; birth constitutes Day 0 4. Parent/legal guardian who has previously decided to exclusively feed infant formula and is willing to continue with formula feeding throughout the study
Exclusion criteria
A participant who meets any of the following criteria will be excluded from participation in the study: 1. Infant born with medical complications (e.g., neurological, cerebral palsy, etc.) 2. 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 3. Infant has been treated with prescription medications that in the Investigator's opinion could impact growth, gastrointestinal tolerance and/or development 4. Infant that has received oral or parenteral antibiotics prior to enrollment 5. Infant is taking and parent/legal guardian plans to continue (including over-the-counter medications, such as Mylicon® for gas), home remedies (such as juice for constipation), gastroesophageal reflux medications, herbal preparations, or rehydration fluids that, in the Investigator's opinion, might affect gastrointestinal tolerance. Use of the following are strongly discouraged for the duration of the trial: 1. Solid foods and juices 2. Vitamins and/mineral supplements, as the study product provided is nutritionally complete 3. Pre- and probiotics 6. Infant with family history (biological siblings or parents) of confirmed milk protein allergy (Parent's lactose intolerance is not disqualifying) 7. Parent(s)/Legal guardian(s) intent on feeding non-study formula, breastmilk, juices, or solid food during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth as compared against WHO growth charts | 16 weeks | Mean daily weight gain for infants fed TF1 and infants fed TF2, each compared to infants fed CF, from baseline through to Week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 16 weeks | Adverse Events reported over the 16-week study period (+4 days) for all groups |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAllan Soo
MD, FAPCR ObvioHealth USA, Inc.
Outcome results
None listed