Effects and Safety of Metronidazole in Patients With Gastrectomy

• Status: Withdrawn
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Recent study showed that SIBO is common among postgastrectomy patients and It appears to be associated with postprandial intestinal symptoms and might aggravate late hypoglycemia. SIBO could be a new therapeutic target for managing intestinal symptoms in postgastrectomy patients.The purpose of this study is to determine whether antiboitic (metronidazole) is effective in patients with postgasrectomy syndrome

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Catholic University of Korea
• Treatments: Metronidazole

Criteria

Inclusion Criteria:

• age between 18 and 70

• gastrectomy for early gastric cancer with complete resection

• no reccurrence after follow up more than 6 months

• identified small bowel bacterial overgrowth by hydrogen breath test

• symptoms of postgastrectomy syndrome

Exclusion Criteria:

• hypersensive to metronidazole

• systemic chemotherapy history

• other organic gastrointestinal disease (inflammatory bowel disease, carcinoid syndrome, amyloidosis, intestinal obstruction)

• other gastrointestinal operation history except appendectomy, cholecystectomy)

• recent colonoscopic examination (within 30 days)

• uncontrolled psychopathy

• drug or alcohol abuser

• pregnant or breast feeding woman

• recent history of antibiotics treatment (within 90 days)

• recent history of PPI or H2 blocker treatment (within 30 dyas)

• recent history of probiotics treatment (within 30 dyas)

• recent history of prokinetics or antispasmotic treatment (within 15 days)

• severe systemic illness