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Goat or Cow Milk Based Infant Formula GMS

NCT06312059 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 409

Last updated 2026-03-24

No results posted yet for this study

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

Interventions

OTHER

Advance Infant Formula Powder

Sole source infant nutrition for the control arm.

OTHER

"Kendamil Cow milk test product

Sole source infant nutrition for the cow milk test arm.

OTHER

"Kendamil goat milk test product

Sole source infant nutrition for the goat milk test arm.

Sponsors & Collaborators

  • ObvioHealth

    collaborator INDUSTRY

  • Kendal Nutricare Ltd

    lead INDUSTRY

Principal Investigators

  • Allan Soo · MD, FAPCR ObvioHealth USA, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-14
Primary Completion
2024-08-15
Completion
2024-08-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06312059 on ClinicalTrials.gov