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Goat or Cow Milk Based Infant Formula GMS

Recruiting
- 14 years of age
Both
Phase 2/3

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Overview

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).

Eligibility

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.

Study details

Growth

NCT06312059

Kendal Nutricare Ltd

19 May 2024

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