An interventional study of Standard infant formula and Infant formula supplemented with HMO in Healthy Growth, sponsored by FrieslandCampina. Terminated at 1 site in United States. Open to participants aged Up to 1 Month, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by FrieslandCampina · Not applicable, Interventional, and Treatment
The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.
FrieslandCampina is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Non-randomized breastfed reference group
Group receiving standard infant formula
Other: Standard infant formula
Group receiving standard infant formula supplemented with HMO
Other: Infant formula supplemented with HMO
Standard infant formula
Infant formula supplemented with HMO
Growth
Infant growth measured as body weight gain per day
Time frame: From enrollment until end of the 3 month-study
Weight
Infant weight (kg)
Time frame: Monthly, from enrollment until end of the 3 month-study
Recumbent length
Infant length (cm and cm/day)
Time frame: Monthly, from enrollment until end of the 3 month-study
Head circumference
Head circumference (cm and cm/day)
Time frame: Monthly, from enrollment until end of the 3 month-study
Anthropometry z-scores
World Health Organization (WHO) growth standard calculated z-scores for weight, length, weight-for-length and head circumference
Time frame: Monthly, from enrollment until end of the 3 month-study
Formula tolerance
Parents are asked to keep a diary on formula intake 3 days prior to each monthly study visit
Time frame: Monthly, from enrollment until end of the 3 month-study
Gastro-intestinal comfort
Parents are asked to keep a diary 3 days prior to each monthly study visit including questions on gastro-intestinal symptoms (e.g. cramps, constipation, vomiting) and crying behavior
Time frame: Monthly, from enrollment until end of the 3 month-study
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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FrieslandCampina