Infantile colic, gastro-esophageal reflux (GER) and constipation are the most common functional gastrointestinal disorders (FGIDs) that lead to referral to a paediatrician during the first six 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 (L. reuteri) DSM 17938 during the first three months of life can reduce the onset of colic, GER and constipation in term newborns and thereby reduce the socio-economic impact of these conditions Design A multicentre double blind randomized clinical trial was performed on term newborns (age <1 week) born at 9 different neonatology 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 (mins/day), the number of evacuations per day, number of visits to paediatricians, feeding changes, hospitalization, visits to Pediatric Emergency Room for a perceived health emergency, pharmacological intervention and loss of parental working days. Participants 589 Infants were randomly allocated to receive L. reuteri DSM 17938 or placebo daily for 90 days. Main Outcomes and Measures Reduction of daily crying time, regurgitation and constipation during the first three months of life. Cost benefit analysis of the probiotic supplementation. Results At three months of age, the mean duration of crying time (38 vs 71 mins; P<0.01), the mean number of regurgitations per day (2.9 vs 4.6; P<0.01) and the mean number of evacuations per day (4.2 vs 3.6; P<0.01) for the L. reuteri and placebo groups, respectively, were significantly different. The use of L. reuteri resulted in an estimated mean saving per patient of €88 for the family and an additional €104 for the community. Conclusion and Relevance Prophylactic use of L. reuteri DSM 17938 during the first three-months of life reduced the onset of FGID and reduced private and public costs for the management of this condition. Trial registration The trial was registered prior to start at ClinicalTrials.gov (National Institutes of Health) with the number NCT01235884.
Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial
Indrio F;
2014-01-01
Abstract
Infantile colic, gastro-esophageal reflux (GER) and constipation are the most common functional gastrointestinal disorders (FGIDs) that lead to referral to a paediatrician during the first six 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 (L. reuteri) DSM 17938 during the first three months of life can reduce the onset of colic, GER and constipation in term newborns and thereby reduce the socio-economic impact of these conditions Design A multicentre double blind randomized clinical trial was performed on term newborns (age <1 week) born at 9 different neonatology 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 (mins/day), the number of evacuations per day, number of visits to paediatricians, feeding changes, hospitalization, visits to Pediatric Emergency Room for a perceived health emergency, pharmacological intervention and loss of parental working days. Participants 589 Infants were randomly allocated to receive L. reuteri DSM 17938 or placebo daily for 90 days. Main Outcomes and Measures Reduction of daily crying time, regurgitation and constipation during the first three months of life. Cost benefit analysis of the probiotic supplementation. Results At three months of age, the mean duration of crying time (38 vs 71 mins; P<0.01), the mean number of regurgitations per day (2.9 vs 4.6; P<0.01) and the mean number of evacuations per day (4.2 vs 3.6; P<0.01) for the L. reuteri and placebo groups, respectively, were significantly different. The use of L. reuteri resulted in an estimated mean saving per patient of €88 for the family and an additional €104 for the community. Conclusion and Relevance Prophylactic use of L. reuteri DSM 17938 during the first three-months of life reduced the onset of FGID and reduced private and public costs for the management of this condition. Trial registration The trial was registered prior to start at ClinicalTrials.gov (National Institutes of Health) with the number NCT01235884.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
