Original study: Study aims to enroll 3-5 children with confirmed Urinary Cycle Disorder (UCD). Subjects meeting the inclusion and exclusion criteria are included during the baseline visit. All subjects will receive the investigational product for a period of 16 weeks. At baseline, 2, 4, 8, 12 and 16 weeks the study parameters are assessed. The study amendment aims to collect case studies retrospectively of children who have used UCD Anamix Infant for at least 16 weeks, in countries where UCD Anamix Infant is already available on the market. It is aimed to collect the same study parameters of the original study at preferably the same timepoints.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
UCD Anamix infant with DHA and ARA is an amino acid based infant medical food containing only the essential amino acids, carbohydrate, fat, vitamins, minerals and trace elements.
Children's hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Growth: weight
weight \[kg\]
Time frame: 16 weeks
Growth: length
length \[cm\]
Time frame: 16 weeks
Growth: head circumference
head circumference \[cm\]
Time frame: 16 weeks
GI symptoms [absent/mild/moderate/severe]
GI symptoms for the following symptoms: * Vomiting (\>1 tablespoon/15ml) * Abdominal distension * Burping * Flatulence * Diarrhoa * Constipation * Colic (cramps) * Regurgitation (\<1 tablespoon/15ml)
Time frame: 16 weeks
Stool frequency
stool frequency \[# times/day\]
Time frame: 16 weeks
Stool consistency
stool consistency: quantification score: \[Watery; Soft, puddinglike; Soft, formed; Dry, formed; Dry, hard pellets\]
Time frame: 16 weeks
Compliance: product intake
Intake of medical food compared to amount prescribed \[ volume: ml per day\]
Time frame: 16 weeks
Protein and iron levels from blood samples (for retrospective study part only if data available)
Protein, amino acids and nutrient levels in blood \[g/dL\] or \[umol/L\]
Time frame: 16 weeks
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