Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation
NCT ID: NCT01235884
Last Updated: 2013-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
492 participants
INTERVENTIONAL
2010-09-30
2012-07-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Lactobacillus reuteri
Dietary Supplement
Lactobacillus reuteri
1000000000 CFU per day (5 drops) for 28 days
Placebo
Dietary Supplement
Placebo
5 drops daily for 28 days
Interventions
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Lactobacillus reuteri
1000000000 CFU per day (5 drops) for 28 days
Placebo
5 drops daily for 28 days
Eligibility Criteria
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Inclusion Criteria
* Recruitment age: until 7 days of life
* Informed consent signed
Exclusion Criteria
* Use of FANS, aspirin or other drugs
* Use of antibiotics and/or PPIs e/o anti-H2
* Participation to other clinical trials
1 Day
7 Days
ALL
Yes
Sponsors
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University of Bari
OTHER
Responsible Party
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Flavia Indrio
Senior Consultant Neonatologist Pediatric Gastroenterologist
Principal Investigators
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Flavia Indrio, MD
Role: PRINCIPAL_INVESTIGATOR
University of Bari
Locations
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University of Bari
Bari, BA, Italy
Ospedale Sant'Orsola Malpighi
Bologna, BO, Italy
Arcispedale S. Anna
Ferrara, FE, Italy
Ospedale Civile
Crotone, KR, Italy
Ospedale di Sesto S. Giovanni
Milan, MI, Italy
Ospedale "SS. Annunziata"
Taranto, TA, Italy
Ospedale "Frà Castoro"
San Bonifacio, VR, Italy
Policlinico "S. Matteo"
Pavia, , Italy
Countries
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References
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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.
Other Identifiers
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FI-RF-01/10
Identifier Type: -
Identifier Source: org_study_id
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