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WithdrawnNCT01658852Updated Sep 21, 2020

Effects and Safety of Metronidazole in Patients With Gastrectomy

A Phase 3 interventional study of metronidazole and Placebo in Post Gastrectomy State, sponsored by The Catholic University of Korea. Withdrawn. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-09-21.

Sponsored by The Catholic University of Korea · Phase 3, Interventional, and Treatment

Why this study was withdrawn
Because of difficulties on recruiting participants
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Post Gastrectomy State
03

In context

Lead sponsor

The Catholic University of Korea is the lead sponsor of 150 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • Drugmetronidazole
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Patient's Global Assessment of abdominal symptom

    Time frame: 4 week

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01658852
Lead sponsor
The Catholic University of Korea
Responsible party
Myung-gui Choi (prof., The Catholic University of Korea) — Principal investigator
First posted
Aug 7, 2012
Start date
May 2011
Primary completion
May 2014
Completion
May 2014 (estimated)
Last update
Sep 21, 2020
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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