This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying and fussing time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Supplementation with drops containing L. reuteri once daily for 21 consecutive days
Supplementation with identical drops without L. reuteri once daily for 21 consecutive days
University of Salento, University Hospital Vito Fazzi Lecce
Lecce, LE, Italy
Crying and fussing time
To evaluate crying and fussing time after 7 days of supplementation with L. reuteri in infants with colic.
Time frame: [Time Frame: From baseline to Day 7]
Crying and fussing time
Change in mean daily crying and fussing time measured by Baby´s Day Diary
Time frame: [Time Frame: From baseline up to Day 21]
Crying time
Change in mean daily crying time measured by Baby´s Day Diary
Time frame: [Time Frame: From baseline up to Day 21]
Number of responders
Proportion of responders defined as reduction of daily average crying time with 50 % compared to baseline
Time frame: [Time Frame: From baseline up to Day 21]
Family quality of life (family QoL)
Change in family QoL measured by the PedsQL Family Impact Module (Acute) - Total Score
Time frame: [Time Frame: From baseline up to Day 21]
Sleeping time
Change in mean sleeping time measured by Baby´s Day Diary
Time frame: [Time Frame: From baseline up to Day 21]
Maternal depression
Change in maternal depression measured by the Edinburgh Postnatal Depression Scale Total Score
Time frame: [Time Frame: From baseline up to Day 21]
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