This study evaluates the efficacy of single strain probiotic administered in a form of a sachet in the treatment of infant colic in infants 3-12 weeks old.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Atlantia Food Clinical Trials
Chicago, Illinois, United States
COMPLETEDPulse Multispeciality Hospital,
Pune, Maharashtra, India
RECRUITINGChange in cry and fuss time
eDiary parent reported cry and fuss time
Time frame: Day 0 , Day 28
Resolution of colic symptoms
Reduction of cry and fuss time (parent reported) greater than 90% comparing to baseline
Time frame: Day 0, Day 28
Change in cry and fuss time bouts
eDiary parent reported cry and fuss bouts
Time frame: Day 0, Day 28
Change in sleeping time
eDiary parent reported sleep time
Time frame: Day 0 Day 28
Change in the use of rescue medications
Change in the proportion of participants needing to use rescue medications between the study arms
Time frame: Day 0, Day 28
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