Effects and Safety of Metronidazole in Patients With Gastrectomy

The Catholic University of Korea

Status and phase

Withdrawn

Phase 3

Conditions

Post Gastrectomy State

Treatments

Drug: Placebo

Drug: metronidazole

Study type

Interventional

Funder types

Other

Identifiers

NCT01658852

Gastrectomy-MDZ-001

Details and patient eligibility

About

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

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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