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Effects and Safety of Metronidazole in Patients With Gastrectomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Myung-gui Choi, The Catholic University of Korea.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01658852
First Posted: August 7, 2012
Last Update Posted: August 7, 2012
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.
Information provided by (Responsible Party):
Myung-gui Choi, The Catholic University of Korea
  Purpose
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 Intervention Phase
Post Gastrectomy State Drug: metronidazole Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Myung-gui Choi, The Catholic University of Korea:

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

Estimated Enrollment: 170
Study Start Date: May 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

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 Submitted: August 3, 2012
First Posted: August 7, 2012
Last Update Posted: August 7, 2012
Last Verified: August 2012

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