Status:
COMPLETED
Efficacy of Lactobacillus GG (LGG) in Children With Abdominal Pain
Lead Sponsor:
University of Bari
Collaborating Sponsors:
Clinica PEdiatrica Ospedale San Paolo Bari Italy
Conditions:
Functional Abdominal Pain
Eligibility:
All Genders
4-14 years
Phase:
NA
Brief 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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00876291
Start Date
December 1 2004
End Date
August 1 2008
Last Update
February 1 2011
Active Locations (1)
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1
Clinica Pediatrica
Bari, Italy, 70100