Prevention of Urinary Tract Infection (UTI) in Persons With Spinal Cord Injury (SCI)
Public ClinicalTrials.gov record NCT00309114. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prevention of UTI in Persons With Spinal Cord Injury
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Urinary tract infection (UTI) is the most common infection in patients with spinal cord injury (SCI) and is linked to major undesired results or complications including death. The bladder of SCI patients, especially those with indwelling catheters, is usually colonized by bacteria, some of which do and others which do not cause symptoms of UTI. Bacteria that do not cause symptoms are often called benign colonizers and are often left untreated because they may provide some protection against infection with more harmful bacteria. This idea of using benign bacteria to prevent infections with symptoms is called bacterial interference. A prototype strain, Escherichia coli 83972, was shown to begin and continue for extended periods of time non symptom causing colonization of the human bladder and to hold back symptom causing infections of the neurogenic bladder. Data from pilot studies at two medical centers indicated that bacterial interference might be a useful therapy for reducing the rate or frequency of UTI in SCI patients. Because almost all SCI patients have a UTI at some time, and also the large costs of treating this infection, studying the impact of bladder colonization with E. coli 83972 on the rate of symptom causing UTI has an amazing potential for improving the quality of life of SCI patients and decreasing the cost of health care. Like with other preventive plans such as vaccination, for instance, it is important to explore the effectiveness of this new preventive approach. The project is a prospective, randomized, double blind, multi-center study that deals with specific pieces of bacterial interference in SCI patients. HYPOTHESES: Placing non symptom causing bacteria (E. coli 83972) into SCI patients' bladders reduces the rate of symptom causing UTI. A. SPECIFIC AIM: Determine how bladder colonization with E. coli 83972 or similar bacteria affects the rate of symptom causing urinary tract infections in a large group of SCI and Spina Bifida patients by conducting a prospective, randomized, placebo-controlled, multi-center clinical trial.
Study identification
- NCT ID
- NCT00309114
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 65 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 15 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2004
- Primary completion
- Oct 31, 2009
- Completion
- Oct 31, 2009
- Last update posted
- Feb 22, 2017
2004 – 2009
United States locations
- U.S. sites
- 5
- U.S. states
- 3
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Shepherd Center | Atlanta | Georgia | 30309 | — |
| Rehab Institute Chicago | Chicago | Illinois | 60611 | — |
| UT Southwestern | Dallas | Texas | 75390 | — |
| Michael E Debakey VA Medical Center | Houston | Texas | 77030 | — |
| The Institute for Rehabilitation and Research (TIRR) | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00309114, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 22, 2017 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00309114 live on ClinicalTrials.gov.