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Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01235884
First Posted: November 8, 2010
Last Update Posted: February 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Flavia Indrio, University of Bari
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Flavia Indrio, University of Bari:

Primary Outcome Measures:
  • Reduction of the onset of gaseous colic, regurgitation and of constipation. [ Time Frame: one year ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 5, 2010
First Posted: November 8, 2010
Last Update Posted: February 5, 2013
Last Verified: February 2013

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

Additional relevant MeSH terms:
Disease
Digestive System Diseases
Pathologic Processes