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

Functional Abdominal Pain Clinical Trial

— LGGDAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876291
• Other study ID #: UB2712
• Status: Completed
• Phase: N/A
• First received: April 2, 2009
• Last updated: January 31, 2011
• Start date: December 2004
• Est. completion date: August 2008

Study information

• Verified date: April 2009
• Source: University of Bari
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 14 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Functional Abdominal Pain

Intervention

Dietary Supplement:
• Lactobacillus GG (probiotic )
LGG capsules: each cp containing 3 × 109 colony forming units, CFU
• 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)

Locations

Country	Name	City	State
Italy	Clinica Pediatrica	Bari

Sponsors (2)

Lead Sponsor	Collaborator
University of Bari	Clinica PEdiatrica Ospedale San Paolo Bari Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure was defined as reduction of pain (both number of episodes and intensity) at the end of the intervention.		12 weeks and 20 weeks	No