ObvioHealth USA, Inc.
New York, 10001, United States
NCT Number: NCT06312059
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).
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All sexes
Interventional
Phase 2 / Phase 3
New York, 10001, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A participant who meets any of the following criteria will be excluded from participation in the study:
Sole source infant nutrition for the control arm.
Sole source infant nutrition for the cow milk test arm.
Sole source infant nutrition for the goat milk test arm.
Time frame: 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
Time frame: 16 weeks
Adverse Events reported over the 16-week study period (+4 days) for all groups
Time frame: 16 weeks
Time frame: 16 weeks
Time frame: 16 weeks
Change from baseline through to Week 16 for infants fed TF1, infants fed TF2, and infants fed CF in:
o mean daily recumbent length gain
Time frame: 16 weeks
Change from baseline through to Week 16 for infants fed TF1, infants fed TF2, and infants fed CF in:
o mean daily head circumference gain
Kendal Nutricare Ltd
Industry
Growth Tolerance and Safety Study of Healthy Term Infants Consuming a Goat or Cow Milk Based Infant Formula
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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