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Human Milk Oligosaccharide Supplement

Formula with HMO for Healthy Growth (Stardust Trial)

N/A
Waitlist Available
Research Sponsored by FrieslandCampina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Being available for follow up until the age of 4 months
Exclusive formula feeding or exclusive breast feeding at time of recruitment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment until end of the 3 month-study
Awards & highlights

Stardust Trial 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.

Stardust Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Stardust Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment until end of the 3 month-study
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until end of the 3 month-study 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
Secondary outcome measures
Anthropometry z-scores
Formula tolerance
Gastro-intestinal comfort
+3 more

Stardust Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Formula with HMOActive Control1 Intervention
Group receiving standard infant formula supplemented with HMO
Group II: Breastfed groupActive Control1 Intervention
Non-randomized breastfed reference group
Group III: Control formulaPlacebo Group1 Intervention
Group receiving standard infant formula

Find a Location

Who is running the clinical trial?

FrieslandCampinaLead Sponsor
34 Previous Clinical Trials
4,832 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~48 spots leftby Mar 2025