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Completed

NCT Number: NCT00280592

Cranberry for 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Cranberry

Drug

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).

Other names: Vaccinium macrocarpon

Placebo

Drug

Placebo presented as sachets of powder. Placebo juice is administered twice a day (in the morning and in the evening).

Primary outcomes

  1. Time to onset of a first UTI within one year of treatment.

    Time frame: one year

Secondary outcomes

  1. Rate of patients with at least one UTI during the one-year treatment

    Time frame: Determined at M3, M6, M9 and M12

  2. Number of UTI

    Time frame: Determined at M3, M6, M9 and M12

  3. Score on Qualiveen® scale

    Time frame: Determined at M3, M6, M9 and M12

  4. Symptomatology of urinary disorders

    Time frame: Determined at M3, M6, M9 and M12

  5. EDSS score

    Time frame: Determined at M3, M6, M9 and M12

  6. Number of multiple sclerosis attacks

    Time frame: Determined at M3, M6, M9 and M12

  7. Antibiotics consumption

    Time frame: Determined at M3, M6, M9 and M12

  8. Safety of cranberry

    Time frame: Determined at M3, M6, M9 and M12

  9. Patients' observance to treatment

    Time frame: Determined at M3, M6, M9 and M12

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Ministry of Health, France
  • Pierre Fabre Laboratories

Registry information

Official study 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.

Acronym: CANNEBERGE

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 23, 2006
Registry last updated
May 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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