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Effects and Safety of Metronidazole in Patients With Gastrectomy

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01658852
Enrollment
0
Registered
2012-08-07
Start date
2011-05-31
Completion date
2014-05-31
Last updated
2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Gastrectomy State

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

Interventions

DRUGmetronidazole
DRUGPlacebo

Sponsors

The Catholic University of Korea
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
Patient's Global Assessment of abdominal symptom4 week

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026