Study Infant Formula
OtherRTF milk-based infant formula with oligosaccharides
NCT Number: NCT04915937
To assess the effects of infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants
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Notify Me7 day–65 day
All sexes
Interventional
Not applicable
MedPharmics, LLC, Phoenix, Arizona, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
RTF milk-based infant formula with oligosaccharides
Time frame: Baseline to Study Day (SDAY) 2
Absolute and % change in fussiness severity reported from Daily Tolerance Diary
Time frame: Baseline to SDAY 28
Parent Completed Diary
Time frame: Baseline to SDAY 28
Parent Completed Diary
Time frame: SDAY 1 to SDAY 28
Parent Completed Diary
Time frame: SDAY 1 to SDAY 28
Weight gains, percentiles, and z-scores
Time frame: SDAY 1 to SDAY 28
Length gains, percentiles, and z-scores
Time frame: SDAY 1 and SDAY 28
Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from frequent to less frequent
Time frame: SDAY 1 and SDAY 28
Parent completed questionnaire; 13 questions of up to 5 categories scaled from positive to negative
Time frame: SDAY 1 and SDAY 28
Parent completed questionnaire; 4, 5-point Likert scale questions, scaled from negative to positive
Time frame: SDAY 7 and SDAY 28
Number of Visits
Time frame: SDAY 1 to SDAY 28
Standard adverse event reporting
Abbott Nutrition
Industry
Tolerance of Term Infants Fed Formula With Oligosaccharides
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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