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

February 18, 2011 updated by: VA New York Harbor Healthcare System
The investigators are finding out if giving antibiotics for Helicobacter pylori will eliminate colonization of the colon by Oxalobacter formigenes.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing upper endoscopy for any indication and who would have determination of presence or absence of H. pylori. Stool samples then positive for colonization with Oxalobacter formigenes.

Description

Inclusion Criteria:

  • age 18-80 years old
  • undergoing upper endoscopy
  • H. pylori present or absent on gastric histology
  • stool positive for Oxalobacter formigenes

Exclusion Criteria:

  • unable to consent
  • stool negative for Oxalobacter formigenes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA New York Harbor Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

February 18, 2011

First Posted (Estimate)

February 21, 2011

Study Record Updates

Last Update Posted (Estimate)

February 21, 2011

Last Update Submitted That Met QC Criteria

February 18, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 573

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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