Goat or Cow Milk Based Infant Formula GMS

Launched by KENDAL NUTRICARE LTD · Mar 12, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two types of infant formulas made from goat's milk and cow's milk to see how well they support healthy growth in infants. The study will compare these formulas to a standard cow's milk formula that is commonly used in the United States. Researchers want to find out if the goat's milk and cow's milk formulas are equally effective in helping infants grow, tolerate the formula, and stay safe while using it.

To participate in this study, infants need to be healthy, born at full term (between 37 to 42 weeks), and weigh between 5.5 to 9.9 pounds at birth. They should be less than 11 days old at the time of enrollment, and their parents must be committed to exclusively using formula for feeding during the study. It's important to note that infants with certain medical conditions or those who have had specific treatments or medications may not qualify. If you join the study, you can expect to feed your baby one of the test formulas while the researchers monitor their growth and overall health. Your participation will help gather valuable information about these infant formulas!

Gender

ALL

Eligibility criteria

• 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.