drugset / Trial / NCT00331994

EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth

NCT00331994

Phase 4 Completed 250 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary objective: to assess the efficacy of Bacillus clausii versus metronidazole in the eradication of the small intestinal bacterial overgrowth, 30 days after the end of treatment. Secondary objective: to assess the efficacy of Bacillus clausii versus metronidazole in avoiding recurrence of the small intestinal bacterial overgrowth, 90 days after the end of the treatment; to assess the efficacy of Bacillus clausiiversus metronidazole in improving irritable bowel syndrome -related symptoms; to assess the efficacy of Bacillus clausii versus metronidazole in the satisfactory relief of overall irritable bowel syndrome symptoms and of abdominal discomfort or pain; to assess the efficacy of Bacillus clausii versus metronidazole in improving irritable bowel syndrome quality of life.

Timeline

Start
2006-04
Primary completion
2008-07
Completion
2008-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Bacillus clausii Other / unclassified
Comparator Metronidazole Small molecule