NCT01658852

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2011

Typical duration for phase_3

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

3 years

First QC Date

August 3, 2012

Last Update Submit

September 17, 2020

Conditions

Post Gastrectomy State

Outcome Measures

Primary Outcomes (1)

  • Patient's Global Assessment of abdominal symptom

    4 week

Study Arms (2)

Metronidazole

ACTIVE COMPARATOR

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

Drug: metronidazole

Placebo

PLACEBO COMPARATOR

Placebo three times per day for 10days

Drug: Placebo

Interventions

metronidazoleDRUG
Metronidazole
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Metronidazole

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof.

Study Record Dates

First Submitted

August 3, 2012

First Posted

August 7, 2012

Study Start

May 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

September 21, 2020

Record last verified: 2020-09