Goat or Cow Milk Based Infant Formula GMS

Kendal Nutricare

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Growth

Treatments: Other: "Kendamil goat milk test product; Other: Advance Infant Formula Powder; Other: "Kendamil Cow milk test product

Study type: Interventional

Funder types: Industry

Identifiers

NCT06312059

KNC-GMS-002

Details and patient eligibility

About

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).

Enrollment: 264 estimated patients

Sex: All

Ages: Under 14 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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264 participants in 3 patient groups

Market leader- Competitor Cow Milk based infant formula

Active Comparator group

Description:

Intervention with Competitor product currently in market- Control.

Treatment:

Other: Advance Infant Formula Powder

Test product Cow Milk based infant formula

Experimental group

Description:

Intervention with Test product product - Test arm.

Treatment:

Other: "Kendamil Cow milk test product

Test product Goat Milk based infant formula

Experimental group

Description:

Intervention with Test product product - Test arm.

Treatment:

Other: "Kendamil goat milk test product