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
  Purpose

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

Condition Intervention
Minor Digestive Disorders
Dietary Supplement: Lactobacillus reuteri
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation.

Resource links provided by NLM:


Further study details as provided by University of Bari:

Primary Outcome Measures:
  • 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


Enrollment: 492
Study Start Date: September 2010
Study Completion Date: July 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235884

Locations
Italy
University of Bari
Bari, BA, Italy, 70124
Ospedale Sant'Orsola Malpighi
Bologna, BO, Italy
Arcispedale S. Anna
Ferrara, FE, Italy
Ospedale Civile
Crotone, KR, Italy
Ospedale di Sesto S. Giovanni
Milano, MI, Italy
Ospedale "SS. Annunziata"
Taranto, TA, Italy
Ospedale "Frà Castoro"
San Bonifacio, VR, Italy
Policlinico "S. Matteo"
Pavia, Italy
Sponsors and Collaborators
University of Bari
Investigators
Principal Investigator: Flavia Indrio, MD University of Bari
  More Information

No publications provided by University of Bari

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Flavia Indrio, Senior Consultant Neonatologist Pediatric Gastroenterologist, University of Bari
ClinicalTrials.gov Identifier: NCT01235884     History of Changes
Other Study ID Numbers: FI-RF-01/10
Study First Received: November 5, 2010
Last Updated: February 4, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Bari:
gaseous colic, regurgitation and of constipation

Additional relevant MeSH terms:
Digestive System Diseases

ClinicalTrials.gov processed this record on August 27, 2014