Effectiveness of XXXX in infantile colic and colicky induced maternal @entity308 : a prospective single blind randomized trial.

@entity1 @entity308 @entity6374
@entity1 colic, excessive crying of unknown cause, is a major burden to families and effects about 10-30  % of @entity1 . Despite decades of research, the exact cause and treatment of @entity1 colic has remained elusive. The use of @entity6374 (DSM 17938) in @entity1 colic is somewhat controversial and hence, we designed this study to evaluate its efficacy in infantile colic. We recruited predominantly or exclusively breastfed @entity1 , aged less than 4  months in a placebo controlled observational randomized study. @entity1 ' were assigned to receive @entity6374 at a dose 10(8) colony forming units (n  =  21) and placebo (n  =  21). Placebo was an identical formulation without live micro-organisms. Treatment was given to subjects for 21  days and they were followed for 4  weeks. Treatment success (primary outcome), daily reduction in crying time, parent satisfaction and @entity308 (secondary outcomes) were assessed at the end of study period. Treatment success was observed in all @entity1 (100  %) of the probiotic group while it was seen in 15.7  % of the placebo group. Mean daily crying time was more significantly reduced to 32.1      8.3  min/day (P  <  0.01) from 200.9      6.3  min/day in the probiotic group as compared to the placebo group (120.6      20.0  min/day). Moreover, throughout the study period, parent's satisfaction and improvement in maternal @entity308 (Edinburgh postnatal @entity308 scale) was also significantly higher in the probiotic group. In our study population, reduction in crying time was significant (P  <  0.01) even during first week of initiation of therapy. We conclude that @entity6374 (DSM 17938) reduces daily crying time and maternal @entity308 during infantile colic. We suggest @entity6374 may be a safe and efficacious option for reducing @entity1 colic.
