Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation

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

Study Overview

• Status: Completed
• Conditions: Minor Digestive Disorders
• Intervention / Treatment: Dietary supplement: Lactobacillus reuteri; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 492
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy
    • Policlinico "S. Matteo"
  • BA
    • Bari, BA, Italy, 70124
      • University of Bari
  • BO
    • Bologna, BO, Italy
      • Ospedale Sant'Orsola Malpighi
  • FE
    • Ferrara, FE, Italy
      • Arcispedale S. Anna
  • KR
    • Crotone, KR, Italy
      • Ospedale Civile
  • MI
    • Milano, MI, Italy
      • Ospedale di Sesto S. Giovanni
  • TA
    • Taranto, TA, Italy
      • Ospedale "SS. Annunziata"
  • VR
    • San Bonifacio, VR, Italy
      • Ospedale "Frà Castoro"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lactobacillus reuteri; Dietary Supplement	Dietary supplement: Lactobacillus reuteri; 1000000000 CFU per day (5 drops) for 28 days
Placebo Comparator: Placebo; Dietary Supplement	Dietary supplement: Placebo; 5 drops daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Bari
• Investigators: Principal Investigator: Flavia Indrio, MD, University of Bari

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: November 5, 2010
• First Submitted That Met QC Criteria: November 5, 2010
• First Posted (Estimate): November 7, 2010

Study Record Updates

• Last Update Posted (Estimate): February 5, 2013
• Last Update Submitted That Met QC Criteria: February 4, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: gaseous colic, regurgitation and of constipation
• Additional Relevant MeSH Terms: Digestive System Diseases
• Other Study ID Numbers: FI-RF-01/10