Goat or Cow Milk Based Infant Formula GMS

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

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).

Study Overview

• Status: Recruiting
• Conditions: Growth
• Intervention / Treatment: Other: "Similac® Advance Infant Formula Powder; Other: "Kendamil Cow milk test product; Other: "Kendamil goat milk test product

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Luke Douglas; Phone Number: +44 (0)7950211990; Email: Luke.Douglas@KendalNutricare.com
• Study Contact Backup: Name: Will McMahon; Phone Number: +44( 0)7484056316; Email: Will.McMahon@kendamil.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Recruiting
      • ObvioHealth USA, Inc.
      • Contact: Parth Shah; Phone Number: 513-571-5377; Email: parth.shah@obviohealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Market leader- Competitor Cow Milk based infant formula; Intervention with Competitor product currently in market- Control.	Other: "Similac® Advance Infant Formula Powder; Sole source infant nutrition for the control arm.
Experimental: Test product Cow Milk based infant formula; Intervention with Test product product - Test arm.	Other: "Kendamil Cow milk test product; Sole source infant nutrition for the cow milk test arm.
Experimental: Test product Goat Milk based infant formula; Intervention with Test product product - Test arm.	Other: "Kendamil goat milk test product; Sole source infant nutrition for the goat milk test arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Adverse Events reported over the 16-week study period (+4 days) for all groups	16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability- Monitoring of stool consistency	• Stool characteristics (using BITSS) at baseline, and Weeks 2, 4, 8, 12, and 16	16 weeks
Tolerability - fussiness	• Formula tolerance (using IGSQ) at baseline, and Weeks 2, 4, 8, 12, and 16	16 weeks
Mean Daily Recumbent Length Gain	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	16 weeks
Mean Daily Head Circumference Gain	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	16 weeks

Collaborators and Investigators

• Sponsor: Kendal Nutricare Ltd
• Collaborators: ObvioHealth
• Investigators: Principal Investigator: Parth Shah, MD, FAPCR ObvioHealth USA, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2023
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: KNC-GMS-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Information to be shared with regulatory agencies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No