Formula with HMO for Healthy Growth

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Healthy Growth
Infant formula supplemented with HMO - Other
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to infants fed standard formula.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: From enrollment until end of the 3 month-study

Month 3
Growth
Month 3
Anthropometry z-scores
Formula tolerance
Gastro-intestinal comfort
Head circumference
Recumbent length
Weight

Trial Safety

Trial Design

3 Treatment Groups

Formula with HMO
1 of 3
Breastfed group
1 of 3
Control formula
1 of 3

Active Control

Non-Treatment Group

279 Total Participants · 3 Treatment Groups

Primary Treatment: Formula with HMO · Has Placebo Group · N/A

Formula with HMO
Other
ActiveComparator Group · 1 Intervention: Infant formula supplemented with HMO · Intervention Types: Other
Breastfed groupNoIntervention Group · 1 Intervention: Breastfed group · Intervention Types:
Control formula
Other
PlaceboComparator Group · 1 Intervention: Standard infant formula · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from enrollment until end of the 3 month-study

Who is running the clinical trial?

FrieslandCampinaLead Sponsor
23 Previous Clinical Trials
1,849 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are < 1 month/age.
You have no recognized diseases (such as cardiac, pulmonary, gastrointestinal, renal or genetic diseases).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: November 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.