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Probiotic for the Prevention of Functional Disorders in Childhood

NCT01671137 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2012-08-23

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Lactobacillus Rhamnosus Strain GG

Lactobacillus Rhamnosus Strain GG

Sponsors & Collaborators

  • University of Bari

    lead OTHER

Principal Investigators

  • Ruggiero Francavilla · University of Bari

  • Ruggiero FRANCAVILLA · DEPARTMENT OF BIOMEDICINA ETA' EVOLUTIVA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-07-31
Completion
2014-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01671137 on ClinicalTrials.gov