Skip to main content
OpenTrials
Completed

NCT Number: NCT00876291

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Pediatrica

Bari, 70100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus GG (probiotic )

Dietary Supplement

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

Placebo

Dietary Supplement

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)

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Collaborators

  • Clinica PEdiatrica Ospedale San Paolo Bari Italy

Registry information

Official study title

The Use of Lactobacillus gg in Functional Abdominal Pain in Children: a Double-blind Randomized Control Trial

Acronym: LGGDAR

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Apr 6, 2009
Registry last updated
Feb 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.