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
UMHAT Deva Maria
Burgas, Bulgaria
RECRUITINGMedical Centre Asklepiy OOD
Dupnitsa, Bulgaria
RECRUITINGAIPSMP
Stara Zagora, Bulgaria
RECRUITINGCrying and fussing time
Change in mean crying and fussing time as assessed by the Baby's Day Diary
Time frame: From baseline to Day 7
Crying and fussing time
Change in mean crying and fussing time as assessed by the Baby's Day Diary
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: From baseline up to Day 21
Family Quality of Life
Change in family QoL measured by the PedsQL Family Impact Module (Acute) - Total Score
Time frame: From baseline up to Day 21
Sleeping time
Change in mean sleeping time as assessed by Baby´s Day Diary
Time frame: From baseline up to Day 21
Maternal depression
Change in maternal depression as assessed by the Edinburgh Postnatal Depression Scale Total Score
Time frame: From baseline up to Day 21
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ipsmp Eood
Stara Zagora, Bulgaria
RECRUITING