This trial is active, not recruiting.

Condition post gastrectomy state
Treatments metronidazole, placebo
Phase phase 3
Sponsor The Catholic University of Korea
Start date May 2011
End date May 2014
Trial size 170 participants
Trial identifier NCT01658852, Gastrectomy-MDZ-001


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
active drug: metronidazole 500mg three time per day for 10 days
(Placebo Comparator)
Placebo three times per day for 10days

Primary Outcomes

Patient's Global Assessment of abdominal symptom
time frame: 4 week

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by The Catholic University of Korea.