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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01300039
First Posted: February 21, 2011
Last Update Posted: February 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VA New York Harbor Healthcare System
  Purpose
The investigators are finding out if giving antibiotics for Helicobacter pylori will eliminate colonization of the colon by Oxalobacter formigenes.

Condition
Nephrolithiasis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Oral Antibiotic Treatment of Helicobacter Pylori Reduces Intestinal Colonization Rates With Oxalobacter Formigenes

Resource links provided by NLM:


Further study details as provided by VA New York Harbor Healthcare System:

Enrollment: 50
Study Start Date: January 2003
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300039


Sponsors and Collaborators
VA New York Harbor Healthcare System
Investigators
Principal Investigator: David S Goldfarb, MD New York Harbor VA Medical Center
  More Information

Responsible Party: David S Goldfarb MD, New York Harbor VA Medical Center
ClinicalTrials.gov Identifier: NCT01300039     History of Changes
Other Study ID Numbers: 573
First Submitted: February 18, 2011
First Posted: February 21, 2011
Last Update Posted: February 21, 2011
Last Verified: February 2011

Keywords provided by VA New York Harbor Healthcare System:
nephrolithiasis
urolithiasis
hyperoxaluria
Helicobacter pylori

Additional relevant MeSH terms:
Nephrolithiasis
Kidney Calculi
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents