Multiple SclerosisPhase 3CANNEBERGENCT00280592
Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients
A Phase 3 study testing Cranberry in people with Multiple Sclerosis and Urinary Tract Infections, run by Rennes University Hospital at 10 sites in France.
Trial summary
Bladder dysfunction occurs at some time in most patients with multiple sclerosis and these patients are prone to have recurrent urinary tract infections. Cranberry has been traditionally used for the treatment and prophylaxis of urinary tract infections but there is no reliable randomized controlled trial… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Urinary Tract Infections, Bladder Dysfunction
- What is being tested?
- Cranberry
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 10 sitesFrance
- Study dates
- Jan 2006to Oct 2008
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 70, with multiple sclerosis, neurologically stable for at least 3 months
- With an EDSS score ≥ 3
- Symptomatic bladder dysfunction: frequency, urgency, dysuria, incontinence (at least one of these symptoms), needing intermittent catheterization or not
- Ambulatory at inclusion
- Able to undergo evaluation
- Informed written consent
Show all 16Show fewer
- Non-inclusion Criteria:
- Regular consumption of cranberry within 3 months before inclusion
- Symptomatic urinary tract infection at inclusion
- Chronic renal failure (creatinin clearance < 10ml/min)
- Patients with urinary permanent catheterization
- Patients with hyperuricemia and risk of uric acid lithiasis
- Patients with oral anticoagulant treatment (antivitamins K)
- Peptic ulcer
- Intolerance to cranberry and/or excipients
- Urinary tract infections antibioprophylaxis
Who cannot join
None listed.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz
Besançon, 25030
Service de Médecine Physique et Réadaptation - Hôpital Pellegrin
Bordeaux, 33076
Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré
Garches, 92380
Consultations maladies infectieuses et tropicales, Hôpital Raymond Poincaré
Garches
Médecine Physique et Réadaptation - Groupe Hospitalier de l'institut Catholique de Lille - Hôpital Saint Philibert
Lomme, 59160
Rééducation Neurologique et Explorations Périnéales - Hôpital Rothschild
Paris, 75571
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE
Ploemeur, 56275
Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou
Rennes, 35033
Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes
Rennes, 35043
Service de médecine physique et réadapation Hopital de Rangueil
Toulouse, 31059
About this study
Official title: Prospective, Randomized, Double-blind, Placebo-controlled Study on Parallel Groups Evaluating the Efficacy and Safety of Cranberry (Vaccinium Macrocarpon) in Prevention of Urinary Tract Infections in Multiple Sclerosis Patients.
Bladder dysfunction occurs at some time in most patients with multiple sclerosis and these patients are prone to have recurrent urinary tract infections. Cranberry has been traditionally used for the treatment and prophylaxis of urinary tract infections but there is no reliable randomized controlled trial demonstrating evidence of cranberry's utility in this disease. The aim of our study is to assess the efficacy and safety of cranberry in the prophylaxis of urinary tract infections in patients with multiple sclerosis with a prospective randomized, double-blind and placebo-controlled clinical trial.
Read the detailed description
Bladder dysfunction occurs at some time in 70 to 90% of patients with multiple sclerosis and these patients are prone to have recurrent urinary tract infections (UTI), leading to an important morbidity. Cranberry has been traditionally used for the treatment and prevention of UTI and research suggests that its mechanism of action is preventing bacterial adherence to host cell surface membrane.
However, systematic reviews show the small sample sizes and the poor quality of available trials, determining that there is no reliable evidence of effectiveness of cranberry in UTI prophylaxis. Therefore, to assess whether cranberry is effective in reducing UTI in patients with multiple sclerosis, we have designed a randomized, double-blind, placebo-controlled trial. Efficacy will be evaluated on the time to onset of a UTI in the first year of treatment.
- Being tested
- Cranberry, Placebo
- Keywords
- Prophylaxis, Cranberry, Neurogenic bladder
- Medical subject headings
- Multiple Sclerosis, Urinary Tract Infections, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CranberryDrug
Also called Vaccinium macrocarpon
Dry essence of cranberry presented as 18 mg of proanthocyanidines sachets of powdered cranberry. Cranberry juice is administered twice a day (in the morning and in the evening).
PlaceboDrug
Placebo presented as sachets of powder. Placebo juice is administered twice a day (in the morning and in the evening).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Cranberry | Experimental | Cranberry Receives: Drug: Cranberry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to onset of a first UTI within one year of treatment.
Measured: one year
Secondary outcomes (9)
Rate of patients with at least one UTI during the one-year treatment
Measured: Determined at M3, M6, M9 and M12
Number of UTI
Measured: Determined at M3, M6, M9 and M12
Score on Qualiveen® scale
Measured: Determined at M3, M6, M9 and M12
Symptomatology of urinary disorders
Measured: Determined at M3, M6, M9 and M12
EDSS score
Measured: Determined at M3, M6, M9 and M12
Number of multiple sclerosis attacks
Measured: Determined at M3, M6, M9 and M12
Antibiotics consumption
Measured: Determined at M3, M6, M9 and M12
Safety of cranberry
Measured: Determined at M3, M6, M9 and M12
Patients' observance to treatment
Measured: Determined at M3, M6, M9 and M12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionMar 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pierre Fabre Laboratories, Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Jean-Michel Reymann, PhD, Study chair, Rennes University HospitalPhilippe Gallien, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280592
- Sponsor's protocol ID
- AFSSAPS 051016
- Other IDs
- PHRC/04-03, CIC0203/039
- Acronym
- CANNEBERGE
- Status last verified
- May 2008
- First submitted
- 20 Jan 2006
- Last updated
- 21 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
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 37068952Gallien P, Amarenco G, Benoit N, Bonniaud V, Donze C, Kerdraon J, de Seze M, Denys P, Renault A, Naudet F, Reymann JM. Cranberry versus placebo in the prevention of urinary infections in multiple sclerosis: a multicenter, randomized, placebo-controlled, double-blind trial. Mult Scler. 2014 Aug;20(9):1252-9. doi: 10.1177/1352458513517592. Epub 2014 Jan 8.
PubMed 24402038
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blind, Placebo-controlled Study on Parallel Groups Evaluating the Efficacy and Safety of Cranberry (Vaccinium Macrocarpon) in Prevention of Urinary Tract Infections in Multiple Sclerosis Patients.
- ClinicalTrials.gov ID
- NCT00280592
- Acronym / sponsor ID
- CANNEBERGE / AFSSAPS 051016
- Keywords
- Prophylaxis, Cranberry, Neurogenic bladder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Pierre Fabre Laboratories, Ministry of Health, France
- Study start
- Jan 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 23 Jan 2006 (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.
Bladder dysfunction occurs at some time in most patients with multiple sclerosis and these patients are prone to have recurrent urinary tract infections. Cranberry has been traditionally used for the treatment and prophylaxis of urinary tract infections but there is no reliable randomized controlled trial demonstrating evidence of cranberry's utility in this disease. The aim of our study is to assess the efficacy and safety of cranberry in the prophylaxis of urinary tract infections in patients with multiple sclerosis with a prospective randomized, double-blind and placebo-controlled clinical trial.
Detailed description
Bladder dysfunction occurs at some time in 70 to 90% of patients with multiple sclerosis and these patients are prone to have recurrent urinary tract infections (UTI), leading to an important morbidity. Cranberry has been traditionally used for the treatment and prevention of UTI and research suggests that its mechanism of action is preventing bacterial adherence to host cell surface membrane.
However, systematic reviews show the small sample sizes and the poor quality of available trials, determining that there is no reliable evidence of effectiveness of cranberry in UTI prophylaxis. Therefore, to assess whether cranberry is effective in reducing UTI in patients with multiple sclerosis, we have designed a randomized, double-blind, placebo-controlled trial. Efficacy will be evaluated on the time to onset of a UTI in the first year of treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Cranberry | Experimental | Drug: CranberryCranberry |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Adults aged 18 to 70, with multiple sclerosis, neurologically stable for at least 3 months
- With an EDSS score ≥ 3
- Symptomatic bladder dysfunction: frequency, urgency, dysuria, incontinence (at least one of these symptoms), needing intermittent catheterization or not
- Ambulatory at inclusion
- Able to undergo evaluation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CranberryAlso: Vaccinium macrocarponDry essence of cranberry presented as 18 mg of proanthocyanidines sachets of powdered cranberry. Cranberry juice is administered twice a day (in the morning and in the evening). | Drug | Cranberry |
| PlaceboPlacebo presented as sachets of powder. Placebo juice is administered twice a day (in the morning and in the evening). | Drug | Placebo |
Primary outcome
Time to onset of a first UTI within one year of treatment.
Time frame: one year
9 secondary outcomes
Rate of patients with at least one UTI during the one-year treatment
Time frame: Determined at M3, M6, M9 and M12
Number of UTI
Time frame: Determined at M3, M6, M9 and M12
Score on Qualiveen® scale
Time frame: Determined at M3, M6, M9 and M12
Symptomatology of urinary disorders
Time frame: Determined at M3, M6, M9 and M12
EDSS score
Time frame: Determined at M3, M6, M9 and M12
Number of multiple sclerosis attacks
Time frame: Determined at M3, M6, M9 and M12
Antibiotics consumption
Time frame: Determined at M3, M6, M9 and M12
Safety of cranberry
Time frame: Determined at M3, M6, M9 and M12
Patients' observance to treatment
Time frame: Determined at M3, M6, M9 and M12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2012.
- 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.
- Derived from this study: PubMed 24402038Gallien P, Amarenco G, Benoit N, Bonniaud V, Donze C, Kerdraon J, de Seze M, Denys P, Renault A, Naudet F, Reymann JM. Cranberry versus placebo in the prevention of urinary infections in multiple sclerosis: a multicenter, randomized, placebo-controlled, double-blind trial. Mult Scler. 2014 Aug;20(9):1252-9. doi: 10.1177/1352458513517592. Epub 2014 Jan 8.
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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.
Jean-Michel Reymann, PhD study chair
Rennes University Hospital
Philippe Gallien, MD principal investigator
Rennes University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cranberry in people with Multiple Sclerosis and Urinary Tract Infections, run by Rennes University Hospital at 10 sites in France.
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 16 inclusion and 0 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: finished, as of the sponsor's last update on 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to onset of a first UTI within one year of treatment. (time frame: one year). 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 NCT00280592, which also lists 3 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 21 May 2012.