Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2010
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
Epistemonikos ID: 8abc189c9386567e3df73b865425e4521bf8cfc3
First added on: May 06, 2024