Spinal Cord InjuryPhase 1NCT00594594
Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord Injury
A Phase 1 study testing Probiotic Lactobacillus GR-1 and RC-14 in people with Spinal Cord Injury and Urinary Tract Infections, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
We hypothesize that probiotic Lactobacillus can augment antibiotic treatment of symptomatic urinary tract infection (UTI) in spinal cord injured patients, and also increase the time to the next episode of UTI. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injury, Urinary Tract Infections
- What is being tested?
- Probiotic Lactobacillus GR-1 and RC-14
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to May 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal cord injury
- UTI
- > 18years
- Male and females
- Prescribed antibiotics
Who cannot join
- Patients who are participating in another clinical study involving pharmaceutical products.
- Patients who are participating in other urology clinical study.
- Patients taking yogurt containing probiotic lactobacilli during the period of the study.
- Females who are pregnant and/or planning to get pregnant during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Centered, Randomized, Double-Blind, Placebo-Controlled Trial for Efficacy in the Use of Adjuntive Probiotic Therapy in Reducing Urinary Tract Infections in Those Individual With Spinal Cord Injury
We hypothesize that probiotic Lactobacillus can augment antibiotic treatment of symptomatic urinary tract infection (UTI) in spinal cord injured patients, and also increase the time to the next episode of UTI.
Read the detailed description
Subjects will be recruited from the outpatient population and 'alumni' of the Regional SCI Rehabilitation Programs in London (Parkwood Hospital/St Joseph's Health Care) and Hamilton (Hamilton Health Sciences Centre) Ontario.
Community living paraplegic and tetraplegic men and women (18 years and above) who present to their family physician or specialist with symptomatic UTI will be prescribed an antibiotic treatment for up to 14 days (using the drug of choice i.e. which the treating physician deems appropriate) and randomized to also receive by mouth two capsules containing placebo or probiotic Lactobacillus rhamnosus GR-1 and L. reuteri RC-14 daily.
- Conditions
- Spinal Cord Injury, Urinary Tract Infections
- Being tested
- Probiotic Lactobacillus GR-1 and RC-14
- Keywords
- spinal cord injury, urinary tract infection, probiotics, Lactobacilli
- Medical subject headings
- Spinal Cord Injuries, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Lactobacillus GR-1 and RC-14Other
Two capsules of Lactobacillus GR-1 and RC-14 daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 Receives: Other: Probiotic Lactobacillus GR-1 and RC-14 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase time to next UTI
Measured: 12 months
Secondary outcomes (1)
Numbers of infections of any type occurring during probiotic treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: Unable to recruit enough patients to continue on with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Investigators
- Patrick J Potter, MD FRCPC, Principal investigator, St. Joseph's Health Care Centre, Parkwood Hospital, Lawson Health Research InstituteGregor Reid, PhD, MBA, Study director, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sKeith Hayes, PhD, Study chair, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sKingsley C Anukam, PhD, Principal investigator, Lawson Health Research Institute, kanukam@uwo.ca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594594
- Sponsor's protocol ID
- R-06-213
- Other IDs
- HSREB 12845
- Status last verified
- Jul 2009
- First submitted
- 4 Jan 2008
- Last updated
- 7 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hayes KC, Bassett-Spiers K, Das R, Ethans KD, Kagan C, Kramer JL, Linsenmeyer T, Moore KN, Razvi H, Reid G, Walter JS, Wilson JW. Research priorities for urological care following spinal cord injury: recommendations of an expert panel. Can J Urol. 2007 Feb;14(1):3416-23.
PubMed 17324320
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centered, Randomized, Double-Blind, Placebo-Controlled Trial for Efficacy in the Use of Adjuntive Probiotic Therapy in Reducing Urinary Tract Infections in Those Individual With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00594594
- Acronym / sponsor ID
- R-06-213
- Conditions
- Spinal Cord Injury, Urinary Tract Infections
- Keywords
- spinal cord injury, urinary tract infection, probiotics, Lactobacilli
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit enough patients to continue on with the study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Study start
- Sep 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that probiotic Lactobacillus can augment antibiotic treatment of symptomatic urinary tract infection (UTI) in spinal cord injured patients, and also increase the time to the next episode of UTI.
Detailed description
Subjects will be recruited from the outpatient population and 'alumni' of the Regional SCI Rehabilitation Programs in London (Parkwood Hospital/St Joseph's Health Care) and Hamilton (Hamilton Health Sciences Centre) Ontario.
Community living paraplegic and tetraplegic men and women (18 years and above) who present to their family physician or specialist with symptomatic UTI will be prescribed an antibiotic treatment for up to 14 days (using the drug of choice i.e. which the treating physician deems appropriate) and randomized to also receive by mouth two capsules containing placebo or probiotic Lactobacillus rhamnosus GR-1 and L. reuteri RC-14 daily.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Probiotic Lactobacillus GR-1 and RC-14Probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Spinal cord injury
- UTI
- > 18years
- Male and females
- Prescribed antibiotics
Key exclusion criteria (4 listed)
- Patients who are participating in another clinical study involving pharmaceutical products.
- Patients who are participating in other urology clinical study.
- Patients taking yogurt containing probiotic lactobacilli during the period of the study.
- Females who are pregnant and/or planning to get pregnant during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Lactobacillus GR-1 and RC-14Two capsules of Lactobacillus GR-1 and RC-14 daily for 12 months | Other | 1 |
Primary outcome
Increase time to next UTI
Time frame: 12 months
1 secondary outcome
Numbers of infections of any type occurring during probiotic treatment
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Unable to recruit enough patients to continue on with the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2009.
- Background: PubMed 17324320Hayes KC, Bassett-Spiers K, Das R, Ethans KD, Kagan C, Kramer JL, Linsenmeyer T, Moore KN, Razvi H, Reid G, Walter JS, Wilson JW. Research priorities for urological care following spinal cord injury: recommendations of an expert panel. Can J Urol. 2007 Feb;14(1):3416-23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J Potter, MD FRCPC principal investigator
St. Joseph's Health Care Centre, Parkwood Hospital, Lawson Health Research Institute
Gregor Reid, PhD, MBA study director
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Keith Hayes, PhD study chair
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Probiotic Lactobacillus GR-1 and RC-14 in people with Spinal Cord Injury and Urinary Tract Infections, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit enough patients to continue on with the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase time to next UTI (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00594594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2009.