NCT01235884

Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation

Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 492 (actual)
• Sponsor: University of Bari · Academic / Other
• Sex: All
• Age: 1 Day – 7 Days
• Healthy volunteers: Accepted

Summary

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

Conditions

• Minor Digestive Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus reuteri	1000000000 CFU per day (5 drops) for 28 days
DIETARY_SUPPLEMENT	Placebo	5 drops daily for 28 days

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-10-01
• Completion: 2012-07-01
• First posted: 2010-11-08
• Last updated: 2013-02-05

Locations

8 sites across 1 country: Italy