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Oral Antibiotic Treatment of Helicobacter Pylori Reduces Intestinal Colonization Rates With Oxalobacter Formigenes

Sponsor
VA New York Harbor Healthcare System (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01300039
Collaborator
(none)
50
Enrollment
65
Duration (Months)

Study Details

Study Description

Brief Summary

The investigators are finding out if giving antibiotics for Helicobacter pylori will eliminate colonization of the colon by Oxalobacter formigenes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Background and objectives: Oxalobacter formigenes (OF) may play a protective role in preventing calcium oxalate stones. Intestinal colonization by OF is associated with reduced urinary oxalate excretion. Exposure to antibiotics may be an important factor contributing to variable rates of colonization. This is the first prospective study to evaluate the effect of antibiotics on OF colonization.

    Design, setting, participants, & measurements: The effect of antibiotics on OF colonization was compared in 2 groups: a group receiving antibiotics for gastric infection with Helicobacter pylori (HP) and a group without HP that not receiving antibiotics. OF colonization in stool was detected by oxalate degradation at baseline and after 1 and 6 months.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Oral Antibiotic Treatment of Helicobacter Pylori Reduces Intestinal Colonization Rates With Oxalobacter Formigenes
    Study Start Date :
    Jan 1, 2003
    Actual Primary Completion Date :
    Jun 1, 2008
    Actual Study Completion Date :
    Jun 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    Antibiotics for H. pylori

    Patients who underwent upper endoscopy and were found to have H. pylori, and were then to be treated with antibiotics for eradication of H. pylori
    Control group, no H. pylori

    Patients who underwent upper endoscopy and found to not have H. pylori, and then would not receive antibiotics

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 80 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • age 18-80 years old

      • undergoing upper endoscopy

        1. pylori present or absent on gastric histology

      • stool positive for Oxalobacter formigenes

      Exclusion Criteria:

      • unable to consent

      • stool negative for Oxalobacter formigenes

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • VA New York Harbor Healthcare System

      Investigators

      • Principal Investigator: David S Goldfarb, MD, New York Harbor VA Medical Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01300039
      Other Study ID Numbers:
      • 573
      First Posted:
      Feb 21, 2011
      Last Update Posted:
      Feb 21, 2011
      Last Verified:
      Feb 1, 2011
      Keywords provided by , ,
      nephrolithiasis
      urolithiasis
      hyperoxaluria
      Helicobacter pylori
      Additional relevant MeSH terms:
      Nephrolithiasis
      Kidney Calculi

      Study Results

      No Results Posted as of Feb 21, 2011