CMPA-GO Study: Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
4
New generation of a whey-based eHF formula intended for the dietary management of infants with CMPA.
Commercial whey-based eHF formula intended for the dietary management of infants with CMPA.
Grupo Pediátrico Uncibay
Málaga, Spain
Growth
To assess the growth by body weight (in g), body length (in cm) and head circumference (in cm) of infants fed with the Test formula, compared to infants fed with the Control formula over 16 weeks of formula use.
Time frame: 16 weeks
Safety via reporting of adverse events (AEs) and serious adverse events (SAEs)
Data gathered by monitoring adverse events with relatedness, seriousness, and severity over 52 weeks.
Time frame: 52 weeks
Tolerability
Tolerability of the formulas assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) and and Cow's Milk-related Symptom Score (CoMiSS®).
Time frame: 52 weeks
Growth
The growth by body weight (in g), body length (in cm) and head circumference (in cm) of infants over 52 weeks.
Time frame: 52 weeks
Stool frequency and characteristics
Stool frequency and characteristics over 52 weeks based on Brussels Infant and Toddler Stool Scale (BITSS).
Time frame: 52 weeks
Quality of life
Quality of life over 52-weeks assessed by by 2 validated QoL scales ("Infant and Toddler Quality of Life" \[ITQOL\] and 'Food hypersensitivity famiLy ImPact' \[FLIP\]).
Time frame: 52 weeks
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