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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 belowStardust Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment until end of the 3 month-study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment until end of the 3 month-study
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 moreStardust 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
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Who is running the clinical trial?
FrieslandCampinaLead Sponsor
34 Previous Clinical Trials
4,832 Total Patients Enrolled
Frequently Asked Questions
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