Minor Digestive Disorders Clinical Trial
Official title:
Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation.
| Verified date | February 2013 |
| Source | University of Bari |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 492 |
| Est. completion date | July 2012 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A to 7 Days |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Italy | University of Bari | Bari | BA |
| Italy | Ospedale Sant'Orsola Malpighi | Bologna | BO |
| Italy | Ospedale Civile | Crotone | KR |
| Italy | Arcispedale S. Anna | Ferrara | FE |
| Italy | Ospedale di Sesto S. Giovanni | Milano | MI |
| Italy | Policlinico "S. Matteo" | Pavia | |
| Italy | Ospedale "Frà Castoro" | San Bonifacio | VR |
| Italy | Ospedale "SS. Annunziata" | Taranto | TA |
| Lead Sponsor | Collaborator |
|---|---|
| University of Bari |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reduction of the onset of gaseous colic, regurgitation and of constipation. | 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 |
one year | Yes |