Effects and Safety of Metronidazole in Patients With Gastrectomy

NCT ID: NCT01658852

Last Updated: 2020-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Post Gastrectomy State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Metronidazole

active drug: metronidazole 500mg three time per day for 10 days

Group Type ACTIVE_COMPARATOR

metronidazole

Intervention Type DRUG

Placebo

Placebo three times per day for 10days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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metronidazole

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Myung-gui Choi

prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Gastrectomy-MDZ-001

Identifier Type: -

Identifier Source: org_study_id

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