Effects and Safety of Metronidazole in Patients With Gastrectomy

September 17, 2020 updated by: Myung-gui Choi, The Catholic University of Korea
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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient's Global Assessment of abdominal symptom
Time Frame: 4 week
4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

August 3, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (Estimate)

August 7, 2012

Study Record Updates

Last Update Posted (Actual)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gastrectomy-MDZ-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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