Comparing goat and cow milk-based infant formulas for growth and safety

Growth Tolerance and Safety Study of Healthy Term Infants Consuming a Goat or Cow Milk Based Infant Formula

This study is testing whether a goat's milk-based infant formula can help healthy babies grow just as well and safely as a cow's milk-based formula.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 264 (estimated)
• Ages: N/A to 14 Days
• Sex: All
• Sponsor: Kendal Nutricare Ltd (Industry-sponsored)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06312059 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the growth, tolerance, and safety of a goat's-milk infant formula compared to a cow's-milk infant formula and a commercially available cow's-milk formula. It is a non-inferiority, randomized, double-blind, controlled trial involving healthy term infants. The study aims to determine if the goat's-milk formula is as effective as the cow's-milk formula in promoting growth in infants. Participants will be monitored for growth metrics and any adverse effects during the trial.

Who should consider this trial

Good fit: Ideal candidates are healthy term infants aged 11 days or younger who are exclusively formula-fed.

Not a fit: Infants with medical complications or growth issues will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a viable alternative for infants who may have sensitivities to cow's milk.

How similar studies have performed: Other studies have explored the use of alternative milk formulas, but this specific comparison of goat versus cow milk formulas is relatively novel.

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.

Where this trial is running

New York, New York

• ObvioHealth USA, Inc. — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Allan Soo — MD, FAPCR ObvioHealth USA, Inc.
• Study coordinator: Luke Douglas

Conditions Growth