Goat or Cow Milk Based Infant Formula GMS (NCT06312059) | Clinical Trial Compass
CompletedPhase 2/3
Goat or Cow Milk Based Infant Formula GMS
United States409 participantsStarted 2023-12-14
Plain-language 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).
Who can participate
Age range14 Days
SexALL
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Inclusion criteria
✓. Healthy term infants (37 to 42 weeks gestation at birth) from a singleton birth as assessed by the investigator
✓. Infants with a birth weight of \>2500 g to \<4500 g
✓. Infants ≤11 days of age at enrollment; birth constitutes Day 0
✓. 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
✕. Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
✕. 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
✕. Infant has been treated with prescription medications that in the Investigator's opinion could impact growth, gastrointestinal tolerance and/or development
✕. Infant that has received oral or parenteral antibiotics prior to enrollment
✕. 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: