Probiotic for the Prevention of Functional Disorders in Childhood

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. Identifier: NCT01671137
Recruitment Status : Unknown
Verified August 2012 by Ruggiero Francavilla, University of Bari.
Recruitment status was:  Not yet recruiting
First Posted : August 23, 2012
Last Update Posted : August 23, 2012
Information provided by (Responsible Party):
Ruggiero Francavilla, University of Bari

Brief Summary:

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 or disease Intervention/treatment Phase
Gastroenteritis Other: Lactobacillus Rhamnosus Strain GG Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2012
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Other: Lactobacillus Rhamnosus Strain GG
Lactobacillus Rhamnosus Strain GG
Other Name: LGG

Primary Outcome Measures :
  1. Prevention of Abdominal pain [ Time Frame: 18 months ]

    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 :
  1. Incidence of IBS [ Time Frame: 6 months ]
    Evaluation of frequency/severity of symptoms according to treatment arm;

  2. Children's health [ Time Frame: 24 months ]
    Evaluation of perception of children's health according to parents

  3. Intestinal microbiota [ Time Frame: 24 months ]
    Investigate the modification of intestinal microbiota.

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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01671137

Contact: Ruggiero Francavilla 0805592963

Clinica Pediatrica Active, not recruiting
Bari, Puglia, Italy, 70125
Sponsors and Collaborators
University of Bari
Principal Investigator: Ruggiero Francavilla University of Bari

Responsible Party: Ruggiero Francavilla, MD, PhD, University of Bari Identifier: NCT01671137     History of Changes
Other Study ID Numbers: PrevenDAR
Prevent-001 ( Other Grant/Funding Number: Uniba001 )
First Posted: August 23, 2012    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

Keywords provided by Ruggiero Francavilla, University of Bari:
Lactobacillus GG
Functional Abdominal Pain

Additional relevant MeSH terms:
Abdominal Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Digestive System Diseases