Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Flavia Indrio, University of Bari
ClinicalTrials.gov Identifier:
NCT01235884
First received: November 5, 2010
Last updated: February 4, 2013
Last verified: February 2013

November 5, 2010
February 4, 2013
September 2010
October 2011   (final data collection date for primary outcome measure)
Reduction of the onset of gaseous colic, regurgitation and of constipation. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

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
Same as current
Complete list of historical versions of study NCT01235884 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Minor Digestive Disorders
  • Dietary Supplement: Lactobacillus reuteri
    1000000000 CFU per day (5 drops) for 28 days
  • Dietary Supplement: Placebo
    5 drops daily for 28 days
  • Active Comparator: Lactobacillus reuteri
    Dietary Supplement
    Intervention: Dietary Supplement: Lactobacillus reuteri
  • Placebo Comparator: Placebo
    Dietary Supplement
    Intervention: Dietary Supplement: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
492
July 2012
October 2011   (final data collection date for primary outcome measure)

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
Both
up to 7 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01235884
FI-RF-01/10
Yes
Flavia Indrio, University of Bari
University of Bari
Not Provided
Principal Investigator: Flavia Indrio, MD University of Bari
University of Bari
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP