Goat or Cow Milk Based Infant Formula GMS

NCT06312059 | Completed Phase 2

• 1 other identifier: KNC-GMS-002
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Growth

Outcome Measures

Primary Outcomes (1)

• Growth as compared against WHO growth charts

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

  16 weeks

Secondary Outcomes (1)

• Safety

  16 weeks

Other Outcomes (4)

• Tolerability- Monitoring of stool consistency

  16 weeks

• Tolerability - fussiness

  16 weeks

• Mean Daily Recumbent Length Gain

  16 weeks

Study Arms (3)

Market leader- Competitor Cow Milk based infant formula

ACTIVE COMPARATOR

Intervention with Competitor product currently in market- Control.

Other: Advance Infant Formula Powder

Test product Cow Milk based infant formula

EXPERIMENTAL

Intervention with Test product product - Test arm.

Other: "Kendamil Cow milk test product

Test product Goat Milk based infant formula

EXPERIMENTAL

Intervention with Test product product - Test arm.

Other: "Kendamil goat milk test product

Interventions

Advance Infant Formula Powder OTHER

Sole source infant nutrition for the control arm.

Market leader- Competitor Cow Milk based infant formula

"Kendamil Cow milk test product OTHER

Sole source infant nutrition for the cow milk test arm.

Test product Cow Milk based infant formula

"Kendamil goat milk test product OTHER

Sole source infant nutrition for the goat milk test arm.

Test product Goat Milk based infant formula

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Kendal Nutricare Ltd: lead
• ObvioHealth: collaborator

Study Sites (1)

ObvioHealth USA, Inc.

New York, New York, 10001, United States

Location

Study Officials

• Allan Soo

  MD, FAPCR ObvioHealth USA, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: RP Over stickered TP in blank packaging.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: March 15, 2024
• Study Start: December 14, 2023
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)