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Test product Cow Milk based infant formula for Growth

Phase 2 & 3

Recruiting

Led By Parth Shah

Research Sponsored by Kendal Nutricare Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

Study Summary

This trial compares the growth, tolerance, and safety of a goat's-milk infant formula and a cow's-milk infant formula to a standard cow's-milk infant formula available in the US.

Who is the study for?

This trial is for healthy infants to compare growth, tolerance, and safety of two test infant formulas: one goat milk-based (TF1) and one cow milk-based (TF2), against a commercially available cow's-milk formula (CF). Specific eligibility details are not provided.Check my eligibility

What is being tested?

The study tests the effects on infant growth between three formulas: Kendamil goat milk formula, Kendamil cow milk formula, and Similac Advance Infant Formula. Infants will be randomly assigned to receive one of these in a double-blind manner.See study design

What are the potential side effects?

Potential side effects are not detailed but may include digestive issues or allergic reactions common with infant formulas. The study aims to ensure that the new formulas are safe and well-tolerated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Growth as compared against WHO growth charts

Secondary outcome measures

Safety

Other outcome measures

Mean Daily Head Circumference Gain

Mean Daily Recumbent Length Gain

Tolerability - fussiness

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Test product Goat Milk based infant formulaExperimental Treatment1 Intervention

Intervention with Test product product - Test arm.

Group II: Test product Cow Milk based infant formulaExperimental Treatment1 Intervention

Intervention with Test product product - Test arm.

Group III: Market leader- Competitor Cow Milk based infant formulaActive Control1 Intervention

Intervention with Competitor product currently in market- Control.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ObvioHealthIndustry Sponsor

11 Previous Clinical Trials

10,996 Total Patients Enrolled

Kendal Nutricare LtdLead Sponsor

Parth ShahPrincipal InvestigatorMD, FAPCR ObvioHealth USA, Inc.

4 Previous Clinical Trials

714 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial currently accepting new participants?

"Indeed, details on clinicaltrials.gov highlight the ongoing recruitment phase for this investigation. Originally shared on December 14th, 2023, and most recently revised on March 12th, 2024, the trial aims to enroll a total of 264 individuals from a single site."

Answered by AI

What is the current number of individuals eligible for enrollment in this clinical research study?

"Indeed, as per clinicaltrials.gov, this investigation is actively seeking volunteers. Its initial posting was on December 14th, 2023, and the most recent update occurred on March 12th, 2024. The research aims to enroll a total of 264 participants from one designated location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Goat or Cow Milk Based Infant Formula GMS

2023. "Goat or Cow Milk Based Infant Formula GMS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06312059.

All > New York City > Philadelphia