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OpenTrials
Completed

NCT Number: NCT06312059

Goat or Cow Milk Based Infant Formula GMS

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).

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Key information

Conditions

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

ObvioHealth USA, Inc.

New York, 10001, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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.

Treatment and study plan

Advance Infant Formula Powder

Other

Sole source infant nutrition for the control arm.

"Kendamil Cow milk test product

Other

Sole source infant nutrition for the cow milk test arm.

"Kendamil goat milk test product

Other

Sole source infant nutrition for the goat milk test arm.

Primary outcomes

  1. Growth as compared against WHO growth charts

    Time frame: 16 weeks

    Mean daily weight gain for infants fed TF1 and infants fed TF2, each compared to infants fed CF, from baseline through to Week 16

Secondary outcomes

  1. Safety

    Time frame: 16 weeks

    Adverse Events reported over the 16-week study period (+4 days) for all groups

Other outcomes

  1. Tolerability- Monitoring of stool consistency

    Time frame: 16 weeks

    • Stool characteristics (using BITSS) at baseline, and Weeks 2, 4, 8, 12, and 16
  2. Tolerability - fussiness

    Time frame: 16 weeks

    • Formula tolerance (using IGSQ) at baseline, and Weeks 2, 4, 8, 12, and 16
  3. Mean Daily Recumbent Length Gain

    Time frame: 16 weeks

    Change from baseline through to Week 16 for infants fed TF1, infants fed TF2, and infants fed CF in:

    o mean daily recumbent length gain

  4. Mean Daily Head Circumference Gain

    Time frame: 16 weeks

    Change from baseline through to Week 16 for infants fed TF1, infants fed TF2, and infants fed CF in:

    o mean daily head circumference gain

Sponsors and collaborators

Lead sponsor

Kendal Nutricare Ltd

Industry

Collaborators

  • ObvioHealth

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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