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Efficacy of Lactobacillus GG (LGG) in Children With Abdominal Pain

NCT00876291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2011-02-01

No results posted yet for this study

Summary

Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria and maintaining the integrity of the gut mucosal barrier. The beneficial effects of probiotics have been previously studied in adult patients with IBS. Even though most of the studies demonstrate efficacy, other studies do not support these observations. Few studies addresses the efficacy of probiotics in children with IBS. The goal of the present study was to determine whether oral administration of the probiotic Lactobacillus GG under randomized, double-blind, placebo-controlled conditions would improve symptoms of children with abdominal pain.

Conditions

  • Functional Abdominal Pain

Interventions

DIETARY_SUPPLEMENT

Lactobacillus GG (probiotic )

LGG capsules: each cp containing 3 × 109 colony forming units, CFU

DIETARY_SUPPLEMENT

Placebo

placebo which consisted of capsules identical in taste and appearance to the active study product except for the absence of freeze-dried LGG (and cryoprotectants)

Sponsors & Collaborators

  • Clinica PEdiatrica Ospedale San Paolo Bari Italy

    collaborator UNKNOWN

  • University of Bari

    lead OTHER

Principal Investigators

  • Ruggiero Francavilla, MD PhD · University of Bari

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2007-12-31
Completion
2008-08-31

Countries

  • Italy

Study Locations

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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 NCT00876291 on ClinicalTrials.gov