Minor Digestive Disorders Clinical Trial
Official title:
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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention