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

This study has been completed.
Sponsor:
Collaborator:
Clinica PEdiatrica Ospedale San Paolo Bari Italy
Information provided by:
University of Bari
ClinicalTrials.gov Identifier:
NCT00876291
First received: April 2, 2009
Last updated: January 31, 2011
Last verified: April 2009
  Purpose

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.


Condition Intervention
Functional Abdominal Pain
Dietary Supplement: Lactobacillus GG (probiotic )
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Lactobacillus gg in Functional Abdominal Pain in Children: a Double-blind Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by University of Bari:

Primary Outcome Measures:
  • The primary outcome measure was defined as reduction of pain (both number of episodes and intensity) at the end of the intervention. [ Time Frame: 12 weeks and 20 weeks ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: December 2004
Study Completion Date: August 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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)
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)
Active Comparator: Probiotic
LGG capsules: each cp containing 3 × 109 colony forming units, CFU
Dietary Supplement: Lactobacillus GG (probiotic )
LGG capsules: each cp containing 3 × 109 colony forming units, CFU

  Eligibility

Ages Eligible for Study:   4 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients were considered for study inclusion, if they were 4 - 12 years of age and had if they had a pain history of at least 12 weeks (which need not be consecutive) in the preceding 12 months suggestive for IBS or FAP with no structural or metabolic abnormalities to explain the symptoms and according to the Rome II diagnostic criteria valid at the time of the design of the study.
  • IBS was diagnosed in presence of an abdominal discomfort or pain with at least two of three features:

    • relieved with defecation
    • onset associated with a change in stool frequency
    • onset associated with a change in the form (appearance) of the stool.
  • FAP was diagnosed in presence of symptoms of
  • Continuous (nearly continuous) abdominal pain
  • No or only occasional relation of pain with physiological events (e.g. eating, menses)
  • Some loss of daily functioning
  • The pain is not feigned (e.g. malingering)
  • The patient has insufficient criteria for other functional gastrointestinal disorders that would explain the abdominal pain.

Exclusion Criteria:

  • Known concomitant psychiatric, neurological, metabolic, hepatic, renal, infectious, haematological, cardiovascular and pulmonary disease
  • Treatment with antibiotics/probiotics in the last 2 months
  • A pain history suggestive for functional dyspepsia or aerophagia or abdominal migrain
  • Growth failure
  • Gastroparesis
  • Gastrointestinal obstructions/stricture
  • Any disease that may affect bowel motility such as diabetes, connective disease or poorly controlled hypo/hyperthyrodism
  • Previous abdominal surgery.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876291

Locations
Italy
Clinica Pediatrica
Bari, Italy, 70100
Sponsors and Collaborators
University of Bari
Clinica PEdiatrica Ospedale San Paolo Bari Italy
Investigators
Principal Investigator: Ruggiero Francavilla, MD PhD University of Bari
  More Information

No publications provided by University of Bari

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinica Pediatrica
ClinicalTrials.gov Identifier: NCT00876291     History of Changes
Other Study ID Numbers: UB2712
Study First Received: April 2, 2009
Last Updated: January 31, 2011
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on April 17, 2014