Effects and Safety of Metronidazole in Patients With Gastrectomy

Phase 3

Withdrawn

• Conditions: Post Gastrectomy State
• Interventions: Drug: Placebo; Drug: metronidazole

• Registration Number: NCT01658852
• Lead Sponsor: The Catholic University of Korea

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-08-03
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-07
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-17
• Last Update Posted: 2020-09-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo three times per day for 10days
Metronidazole	metronidazole	active drug: metronidazole 500mg three time per day for 10 days

Primary Outcome Measures

Name	Time	Method
Patient's Global Assessment of abdominal symptom	4 week