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Effects and Safety of Metronidazole in Patients With Gastrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01658852
Recruitment Status : Withdrawn (Because of difficulties on recruiting participants)
First Posted : August 7, 2012
Last Update Posted : September 21, 2020
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2011
Actual Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

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 ]

Information from the National Library of Medicine

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

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
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Responsible Party: Myung-gui Choi, prof., The Catholic University of Korea Identifier: NCT01658852    
Other Study ID Numbers: Gastrectomy-MDZ-001
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents