Clinical trial NCT01235884: Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation
Official title: Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Minor Digestive Disorders
Keywords: gaseous colic, regurgitation and of constipation
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2010-11-07
Enrollment: 492
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Reduction of the onset of gaseous colic, regurgitation and of constipation.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: University of Bari
state: BA
city: Bologna
country: Italy
facility: Ospedale Sant'Orsola Malpighi
state: BO
city: Ferrara
country: Italy
facility: Arcispedale S. Anna
state: FE
city: Crotone
country: Italy
facility: Ospedale Civile
state: KR
city: Milano
country: Italy
facility: Ospedale di Sesto S. Giovanni
state: MI
city: Taranto
country: Italy
facility: Ospedale "SS. Annunziata"
state: TA
city: San Bonifacio
country: Italy
facility: Ospedale "Frà Castoro"
state: VR
city: Pavia
country: Italy
facility: Policlinico "S. Matteo"
Study officials:
affiliation: University of Bari
name: Flavia Indrio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.