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Probiotic for the Prevention of Functional Disorders in Childhood

This study is not yet open for participant recruitment.
Verified August 2012 by University of Bari
Sponsor:
Information provided by (Responsible Party):
Ruggiero Francavilla, University of Bari
ClinicalTrials.gov Identifier:
NCT01671137
First received: August 16, 2012
Last updated: August 20, 2012
Last verified: August 2012
History of Changes
  Purpose

The present study has several aims:

  1. Establish whether Lactobacillus Rhamnosus Strain GG is able to prevent the onset of IBS in a high risk group of children enrolled after an acute gastroenteritis (the study has been powered to this aim).
  2. Establish whether Lactobacillus Rhamnosus Strain GG is able to stabilize the intestinal microbiota after an acute gastroenteritis.
  3. Define the intestinal microbiota of children following an acute gastroenteritis and identify, if possible, a modification of the microbiota that can predict the emergence of Irritable Bowel Syndrome.

Condition Intervention
Gastroenteritis
 Other: Lactobacillus Rhamnosus Strain GG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Lactobacillus Rhamnosus Strain GG for The Prevention of Functional Abdominal Pain Children After Acute Gastroenteritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Bari:

Primary Outcome Measures:
  • Prevention of Abdominal pain [ Time Frame: 18 months ] [ Designated as safety issue: No ]

    Primary outcome will be the incidence in IBS in children receiving LGG as compared to those receiving placebo. We have chosen pain as the primary outcome measure, in line with the proposed points-toconsider for IBS trials (Corazziari E. Consensus report: Clinical trial guidelines for pharmacological treatment of irritable bowel syndrome. Aliment Pharmcol Ther 2003;18:569).

    IBS or chronic abdominal pain will be diagnosed and categorised according to ROME III criteria (Rasquin A, Di Lorenzo C, Forbes D, et al. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006;130).



Secondary Outcome Measures:
  • Incidence of IBS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluation of frequency/severity of symptoms according to treatment arm;

  • Children's health [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Evaluation of perception of children's health according to parents

  • Intestinal microbiota [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Investigate the modification of intestinal microbiota.


Estimated Enrollment: 400
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lactobacillus Rhamnosus Strain GG
LGG (6 × 109 colony forming units)
 Other: Lactobacillus Rhamnosus Strain GG
Lactobacillus Rhamnosus Strain GG
Other Name: LGG
Placebo Comparator: Placebo
Placebo
 Other: Lactobacillus Rhamnosus Strain GG
Lactobacillus Rhamnosus Strain GG
Other Name: LGG

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children of 3 - 16 years of age;
  2. Either sex.

Exclusion Criteria:

  1. Chronic disease,
  2. Clinical history of abdominal pain history suggestive for functional dyspepsia/aerophagia/abdominal migraine
  3. Growth failure,
  4. Alarm signs of organic conditions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671137

Contacts
Contact: Ruggiero Francavilla 0805592963 rfrancavilla@gmail.com

Locations
Italy
Clinica Pediatrica Active, not recruiting
Bari, Puglia, Italy, 70125
Sponsors and Collaborators
University of Bari
Investigators
Principal Investigator: Ruggiero Francavilla University of Bari
Principal Investigator: Ruggiero FRANCAVILLA DEPARTMENT OF BIOMEDICINA ETA' EVOLUTIVA
  More Information

No publications provided

Responsible Party: Ruggiero Francavilla, MD, PhD, University of Bari
ClinicalTrials.gov Identifier: NCT01671137     History of Changes
Other Study ID Numbers: PrevenDAR, Prevent-001
Study First Received: August 16, 2012
Last Updated: August 20, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Bari:
Lactobacillus GG
Functional Abdominal Pain
Children
Acute
Gastroenteritis

Additional relevant MeSH terms:
Abdominal Pain
Gastroenteritis
Pain
Signs and Symptoms
 Signs and Symptoms, Digestive
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013