Goat or Cow Milk Based Infant Formula GMS

Completed · Phase 2/Phase 3

Conditions studied: Growth

In brief

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).

Key facts

Study ID

NCT06312059

Run by

Kendal Nutricare Ltd

People needed

409

Starts

2023-12-14

Expected to finish

2024-08-15

Last updated by the study team

2026-03-24

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• A participant who meets any of the following criteria will be excluded from participation in the study:
• 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:
• Solid foods and juices
• Vitamins and/mineral supplements, as the study product provided is nutritionally complete
• Pre- and probiotics
• Infant with family history (biological siblings or parents) of confirmed milk protein allergy (Parent's lactose intolerance is not disqualifying)
• Parent(s)/Legal guardian(s) intent on feeding non-study formula, breastmilk, juices, or solid food during the study.

Where it is running

• ObvioHealth USA, Inc. — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.