Goat or Cow Milk Based Infant Formula GMS

Growth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06312059
• Other study ID #: KNC-GMS-002
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 14, 2023
• Est. completion date: August 15, 2024

Study information

• Verified date: December 2023
• Source: Kendal Nutricare Ltd
• Contact: Luke Douglas
• Phone: +44 (0)7950211990
• Email: Luke.Douglas[@]KendalNutricare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: August 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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.

Related Conditions & MeSH terms

• Growth

Intervention

Other:
• Advance Infant Formula Powder
Sole source infant nutrition for the control arm.
• "Kendamil Cow milk test product
Sole source infant nutrition for the cow milk test arm.
• "Kendamil goat milk test product
Sole source infant nutrition for the goat milk test arm.

Locations

Country	Name	City	State
United States	ObvioHealth USA, Inc.	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Kendal Nutricare Ltd	ObvioHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tolerability- Monitoring of stool consistency	• Stool characteristics (using BITSS) at baseline, and Weeks 2, 4, 8, 12, and 16	16 weeks
Other	Tolerability - fussiness	• Formula tolerance (using IGSQ) at baseline, and Weeks 2, 4, 8, 12, and 16	16 weeks
Other	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
Other	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
Primary	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	Safety	Adverse Events reported over the 16-week study period (+4 days) for all groups	16 weeks