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

This study has been completed.
Sponsor:
Information provided by:
VA New York Harbor Healthcare System
ClinicalTrials.gov Identifier:
NCT01300039
First received: February 18, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: David S Goldfarb MD, New York Harbor VA Medical Center
ClinicalTrials.gov Identifier: NCT01300039     History of Changes
Other Study ID Numbers: 573
Study First Received: February 18, 2011
Last Updated: February 18, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 16, 2014