NCT01300039

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Status
completed

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

January 1, 2003

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
Last Updated

February 21, 2011

Status Verified

February 1, 2011

Enrollment Period

5.4 years

First QC Date

February 18, 2011

Last Update Submit

February 18, 2011

Conditions

Nephrolithiasis

Keywords

nephrolithiasisurolithiasishyperoxaluriaHelicobacter pylori

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • unable to consent
  • stool negative for Oxalobacter formigenes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NephrolithiasisUrolithiasisHyperoxaluria

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • David S Goldfarb, MD

    New York Harbor VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 21, 2011

Study Start

January 1, 2003

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 21, 2011

Record last verified: 2011-02