The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic. Primary hypothesis to be tested is: an infant formula with optimized composition improves colicky symptoms compared to a standard formula.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
169
commercial stage 1 infant formula
infant formula with hydrolyzed protein (type I) and pre- and probiotics
infant formula with hydrolyzed protein (type II) and pre- and probiotics
Pediatric Office
Düsseldorf, Germany
Pediatric Office
Kehl, Germany
Pediatric Office
Mülheim, Germany
daily total crying time
evaluation of the difference in the average reduction of daily crying time after 28 days of intervention between treatment and control group
Time frame: 28 days
growth parameters
determination of body weight, length, head circumference
Time frame: 90 days
tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects
stool characteristics: frequency, consistency and color; gastrointestinal disorders: regurgitation, obstipation; side effects: vomiting, diarrhea, skin reactions
Time frame: 28 days
formula intake
evaluation of average daily drinking amount and formula acceptance
Time frame: 28 days
intestinal microbiota
evaluation of changes in the composition of the intestinal microbiota (Lactobacilli, Bifidobacteria, Coliforms) after intervention
Time frame: 0-28 days
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...and 8 more locations