AUTHORS ' CONCLUSIONS There is no clear evidence that probiotics are more effective than placebo at preventing infantile colic ; however , daily crying time appeared to reduce with probiotic use compared to placebo .
There were no clear differences in adverse effects .
BACKGROUND Infantile colic is typically defined as full-force crying for at least three hours per day , on at least three days per week , for at least three weeks .
Infantile colic affects a large number of infants and their families worldwide .
Its symptoms are broad and general , and while not indicative of disease , may represent a serious underlying condition in a small percentage of infants who may need a medical assessment .
Probiotics are live microorganisms that alter the microflora of the host and provide beneficial health effects .
The most common probiotics used are of Lactobacillus , Bifidobacterium and Streptococcus .
There is growing evidence to suggest that intestinal flora in colicky infants differ from those in healthy infants , and it is suggested that probiotics can redress this balance and provide a healthier intestinal microbiota l and scape .
The low cost and easy availability of probiotics makes them a potential prophylactic solution to reduce the incidence and prevalence of infantile colic .
OBJECTIVES To evaluate the efficacy and safety of prophylactic probiotics in preventing or reducing severity of infantile colic .
Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial.
IMPORTANCE Infantile colic , gastroesophageal reflux , and constipation are the most common functional gastrointestinal disorders that lead to referral to a pediatrician during the first 6 months of life and are often responsible for hospitalization , feeding changes , use of drugs , parental anxiety , and loss of parental working days with relevant social consequences . OBJECTIVE To investigate whether oral supplementation with Lactobacillus reuteri DSM 17938 during the first 3 months of life can reduce the onset of colic , gastroesophageal reflux , and constipation in term newborns and thereby reduce the socioeconomic impact of these conditions . DESIGN A prospect i ve , multicenter , double-masked , placebo-controlled r and omized clinical trial was performed on term newborns ( age < 1 week ) born at 9 different neonatal units in Italy between September 1 , 2010 , and October 30 , 2012 . SETTING Parents were asked to record in a structured diary the number of episodes of regurgitation , duration of inconsolable crying ( minutes per day ) , number of evacuations per day , number of visits to pediatricians , feeding changes , hospitalizations , visits to a pediatric emergency department for a perceived health emergency , pharmacologic interventions , and loss of parental working days . PARTICIPANTS In total , 589 infants were r and omly allocated to receive L reuteri DSM 17938 or placebo daily for 90 days . INTERVENTIONS Prophylactic use of probiotic . MAIN OUTCOMES AND MEASURES Reduction of daily crying time , regurgitation , and constipation during the first 3 months of life . Cost-benefit analysis of the probiotic supplementation . RESULTS At 3 months of age , the mean duration of crying time ( 38 vs 71 minutes ; P < .01 ) , the mean number of regurgitations per day ( 2.9 vs 4.6 ; P < .01 ) , and the mean number of evacuations per day ( 4.2 vs 3.6 ; P < .01 ) for the L reuteri DSM 17938 and placebo groups , respectively , were significantly different . The use of L reuteri DSM 17938 result ed in an estimated mean savings per patient of € 88 ( US $ 118.71 ) for the family and an additional € 104 ( US $ 140.30 ) for the community . CONCLUSIONS AND RELEVANCE Prophylactic use of L reuteri DSM 17938 during the first 3 months of life reduced the onset of functional gastrointestinal disorders and reduced private and public costs for the management of this condition . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01235884
AUTHORS ' CONCLUSIONS There is no clear evidence that probiotics are more effective than placebo at preventing infantile colic ; however , daily crying time appeared to reduce with probiotic use compared to placebo .
There were no clear differences in adverse effects .
BACKGROUND Infantile colic is typically defined as full-force crying for at least three hours per day , on at least three days per week , for at least three weeks .
Infantile colic affects a large number of infants and their families worldwide .
Its symptoms are broad and general , and while not indicative of disease , may represent a serious underlying condition in a small percentage of infants who may need a medical assessment .
Probiotics are live microorganisms that alter the microflora of the host and provide beneficial health effects .
The most common probiotics used are of Lactobacillus , Bifidobacterium and Streptococcus .
There is growing evidence to suggest that intestinal flora in colicky infants differ from those in healthy infants , and it is suggested that probiotics can redress this balance and provide a healthier intestinal microbiota l and scape .
The low cost and easy availability of probiotics makes them a potential prophylactic solution to reduce the incidence and prevalence of infantile colic .
OBJECTIVES To evaluate the efficacy and safety of prophylactic probiotics in preventing or reducing severity of infantile colic .