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Effects and Safety of Metronidazole in Patients With Gastrectomy

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ClinicalTrials.gov Identifier: NCT01658852
Recruitment Status : Unknown
Verified August 2012 by Myung-gui Choi, The Catholic University of Korea.
Recruitment status was:  Active, not recruiting
First Posted : August 7, 2012
Last Update Posted : August 7, 2012
Sponsor:
Information provided by (Responsible Party):
Myung-gui Choi, 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

Condition or disease Intervention/treatment Phase
Post Gastrectomy State Drug: metronidazole Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2011
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Metronidazole
active drug: metronidazole 500mg three time per day for 10 days
Drug: metronidazole
Placebo Comparator: Placebo
Placebo three times per day for 10days
Drug: Placebo



Primary Outcome Measures :
  1. Patient's Global Assessment of abdominal symptom [ Time Frame: 4 week ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Responsible Party: Myung-gui Choi, prof., The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01658852     History of Changes
Other Study ID Numbers: Gastrectomy-MDZ-001
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents