Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation

Aim of the study. To evaluate if L. reuteri DSM 17938 supplementation since the first days of life can reduce the onset of gaseous colic in neonates and the onset of minor digestive disorders such as regurgitation and constipation. Study Design. Double blind, randomized, controlled, multicenter study. 492 neonates of 37-42 gestational age, breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or placebo for 28 days. After the inclusion, at baseline will be performed : Paediatric visit antropometric valutation number of the daily crying minutes, number of regurgitation and number of daily evacuation The patients will receive the probiotics/placebo every days for 28 days and the 29th will be repeated the following analyses: Paediatric visit antropometric valutation number of daily crying minutes numbers of regurgitation numbers of evacuations Primary outcome : To define if Lactobacillus reuteri supplementation can reduce the onset of gaseous colic, regurgitation and of constipation. Inclusion criteria neonates of 37-42 week gestational age and appropriate birth weight Recruitment age: until 7 days of life Informed consent signed Exclusion criteria Presence of other gastrointestinal diseases. Use of FANS, aspirin or other drugs Use of antibiotics and/or PPIs e/o anti-H2 Participation to other clinical trials

After the inclusion, at baseline will be performed : Paediatric visit antropometric valutation number of the daily crying minutes, number of regurgitation and number of daily evacuation The patients will receive the probiotics/placebo every days for 28 days and the 29th will be repeated the following analyses: Paediatric visit antropometric valutation number of daily crying minutes numbers of regurgitation numbers of evacuations

Inclusion Criteria: neonates of 37-42 week gestational age and appropriate birth weight Recruitment age: until 7 days of life Informed consent signed Exclusion Criteria: Presence of other gastrointestinal diseases. Use of FANS, aspirin or other drugs Use of antibiotics and/or PPIs e/o anti-H2 Participation to other clinical trials

Indrio F, Di Mauro A, Riezzo G, Civardi E, Intini C, Corvaglia L, Ballardini E, Bisceglia M, Cinquetti M, Brazzoduro E, Del Vecchio A, Tafuri S, Francavilla R. Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):228-33. doi: 10.1001/jamapediatrics.2013.4367.