Spinal Cord InjuryNCT01079169
Effect of Cranberry Capsules on Urinary Infection Rates in Spinal Cord Injured Patients During Post Acute Rehabilitation
A study testing Cranberry capsules in people with Spinal Cord Injury and Urinary Tract Infection, run by Uppsala University at 1 site in Sweden.
Trial summary
The purpose of this study is to establish whether cranberry capsules reduce rates of urinary tract infections during initial rehabilitation immediately after spinal cord injury. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injury, Urinary Tract Infection, Rehabilitation
- What is being tested?
- Cranberry capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2010to Mar 2012
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Previously essentially healthy
- Newly acquired spinal cord injury, T12 level or higher
- Receiving in-patient care on the rehabilitation ward.
- Expected admission duration >= 4 weeks
- 16 years old or older
Who cannot join
- Current or previous disorder that increases the risk of urinary tract infection including diabetes, urological disorder, previous operation on urinary tracts or kidneys, immune dysfunction
- Severe head injury with impairment of cognitive function
- Allergy to cranberry
- Renal failure
- Warfarin (Coumarin) treatment with unstable INR
- Current symptomatic urinary tract infection
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Rehabilitation Medicine, University Hospital
Uppsala, 75185
About this study
Official title: Evaluation of the Effect of Cranberry Capsules on the Occurrence of Urinary Tract Infections During Post-acute Rehabilitation of Spinal Cord Injured Patients
The purpose of this study is to establish whether cranberry capsules reduce rates of urinary tract infections during initial rehabilitation immediately after spinal cord injury.
- Conditions
- Spinal Cord Injury, Urinary Tract Infection, Rehabilitation
- Being tested
- Cranberry capsules
- Keywords
- urinary tract infection, prevention, rehabilitation, spinal cord injury
- 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.
Cranberry capsulesDietary supplement
Cranberry capsules, 550mg, or placebo capsules, two capsules three times daily during in-patient rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Cranberry capsule | Experimental | Not described Receives: Dietary Supplement: Cranberry capsules |
| Placebo capsule | Placebo comparator | Not described Receives: Dietary Supplement: Cranberry capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of symptomatic urinary tract infections per patient per month during in-patient post acute rehabilitation
Measured: At end of study
Secondary outcomes (2)
Percentage of in-patient rehabilitation days on which patients were unable to participate in active rehabilitation due to urinary tract infection.
Measured: At end of Study
Patient's experience of urinary symptoms in the absence of symptomatic urinary tract infection.
Measured: At end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Terminated early due to recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Uppsala UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison K Godbolt, MbChB MD, Principal investigator, University Hospital Uppsala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079169
- Sponsor's protocol ID
- 2009/280
- Status last verified
- May 2016
- First submitted
- 19 Feb 2010
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.
PubMed 37947276Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.
PubMed 37068952
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Cranberry Capsules on the Occurrence of Urinary Tract Infections During Post-acute Rehabilitation of Spinal Cord Injured Patients
- ClinicalTrials.gov ID
- NCT01079169
- Acronym / sponsor ID
- 2009/280
- Conditions
- Spinal Cord Injury, Urinary Tract Infection, Rehabilitation
- Keywords
- urinary tract infection, prevention, rehabilitation, spinal cord injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated early due to recruitment difficulties
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Mar 2010 (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.
The purpose of this study is to establish whether cranberry capsules reduce rates of urinary tract infections during initial rehabilitation immediately after spinal cord injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry capsule | Experimental | Dietary Supplement: Cranberry capsules |
| Placebo capsule | Placebo comparator | Dietary Supplement: Cranberry capsules |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Previously essentially healthy
- Newly acquired spinal cord injury, T12 level or higher
- Receiving in-patient care on the rehabilitation ward.
- Expected admission duration >= 4 weeks
- 16 years old or older
Key exclusion criteria (6 listed)
- Current or previous disorder that increases the risk of urinary tract infection including diabetes, urological disorder, previous operation on urinary tracts or kidneys, immune dysfunction
- Severe head injury with impairment of cognitive function
- Allergy to cranberry
- Renal failure
- Warfarin (Coumarin) treatment with unstable INR
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 |
|---|---|---|
| Cranberry capsulesCranberry capsules, 550mg, or placebo capsules, two capsules three times daily during in-patient rehabilitation | Dietary supplement | Cranberry capsule, Placebo capsule |
Primary outcome
Number of symptomatic urinary tract infections per patient per month during in-patient post acute rehabilitation
Time frame: At end of study
2 secondary outcomes
Percentage of in-patient rehabilitation days on which patients were unable to participate in active rehabilitation due to urinary tract infection.
Time frame: At end of Study
Patient's experience of urinary symptoms in the absence of symptomatic urinary tract infection.
Time frame: At end of study
Results and safety
The study was stopped early (reason given: Terminated early due to recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Derived from this study: PubMed 37947276Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.
- Derived from this study: PubMed 37068952Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.
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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.
Alison K Godbolt, MbChB MD principal investigator
University Hospital Uppsala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry capsules in people with Spinal Cord Injury and Urinary Tract Infection, run by Uppsala University at 1 site in Sweden.
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 6 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 16 May 2016. 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 Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated early due to recruitment difficulties). 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?
Number of symptomatic urinary tract infections per patient per month during in-patient post acute rehabilitation (time frame: At end of study). 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 NCT01079169, which also lists 2 linked publications.
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 16 May 2016.