D-mannose for the Prevention of UTIs in Multiple Sclerosis
NCT ID: NCT02490046
Last Updated: 2015-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2015-02-28
2015-11-30
Brief Summary
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This will be explored through:
1. Assessing compliance to a 16-week course of D-mannose
2. Quantifying the number of prescriptions for antibiotics during the 16 weeks course of D-mannose
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Detailed Description
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Screening Period: Before any screening procedures occur, participants will sign an Informed Consent Form.
During the screening evaluation the following procedures will be conducted and recorded for all patients:
* Informed Consent
* Evaluation of compliance with inclusion and exclusion criteria
* Demography and Past Medical History
* Vital signs including weight
* Physical examination including neurological examination
* Review of concomitant medications
Baseline assessments: A urine sample will be tested for an infection using Urine multistix in the Department of Uro-neurology, which is a routine clinical practice. Participants will enter a discussion about the symptoms of a urinary tract infection and be taught the use of Urine multistix. They will complete standardised validated questionnaires for overactive bladder syndrome (ICIQ-OAB, sf-Qualiveen® and EQ5D-5L™).
Treatment procedures: Patients will receive D-mannose powder to be used 1.5 gm (one level-teaspoon) twice daily, to be added to any beverage, for 16 weeks. D-mannose is classed as a food supplement and is widely available in the United Kingdom for purchase. D-Mannose will be sourced from D-Mannose Limited.
Subsequent assessments: Compliance will be assessed by using a Usage diary, on which the use of D-mannose will be marked and any problems noted. Acceptability and tolerability to D-mannose will be assessed through the diary. Additionally, patients will be phoned after one week, and after 8 weeks, to enquire about well-being and compliance.
Participants will be asked to note the number of prescriptions they receive during the 16 week course in a urinary tract infection diary. Suspected self-reported urinary tract infections will be noted in a diary, as well as the results of the urine multistix. Standard clinical practice will be followed and participants with a suspected urinary tract infection will inform their general practitionner, mid-stream urine samples sent to the lab and antibiotic treatment started. Patients will continue to take D-mannose. The usage diary has to be sent by the patients every week.
At week 16, patients will be asked to return for a second visit. Compliance and urinary tract infection diaries will be collected and reviewed. They will be asked to complete questionnaires (ICIQ-OAB, sf-Qualiveen® and EQ5D-5L™) and neurological status will be evaluated.
The study will be conducted in accordance with the International Conference on Harmonization Good Clinical Practice guidelines and the Declaration of Helsinki, and within local laws and regulations.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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MS and rec UTIs not using a catheter
people with multiple sclerosis and recurrent urinary tract infections with spontaneous voiding Intervention- will be given D-mannose
D Mannose
Patients in both arms will receive D-mannose powder to be used 1.5 gm (one level-teaspoon) twice daily, to be added to any beverage, for 16 weeks.
MS and rec UTIs using a catheter
people with multiple sclerosis and recurrent urinary tract infections using either urethral or suprapubic indwelling catheter or intermittent catheterisation Intervention- will be given D-mannose
D Mannose
Patients in both arms will receive D-mannose powder to be used 1.5 gm (one level-teaspoon) twice daily, to be added to any beverage, for 16 weeks.
Interventions
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D Mannose
Patients in both arms will receive D-mannose powder to be used 1.5 gm (one level-teaspoon) twice daily, to be added to any beverage, for 16 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Patient with recurrent urinary tract infections, defined as having at least two urinary tract infections in the preceding six months or three or more urinary tract infections in the preceding one year. Urinary tract infections were defined retrospectively by patient self-report and confirmation by urine culture.
3. Age over 18 years and below 65
4. Females of childbearing potential using effective contraception if sexually active - oral contraceptive pill (\> 3 months use), condoms, intrauterine contraceptive device, depot injection
Exclusion Criteria
2. Breastfeeding
3. History of congenital urinary tract anomalies or interstitial cystitis
4. History of diabetes mellitus
5. Receiving antibiotic prophylaxis or cranberry extract preparations
6. Current urinary tract infection
7. Current vaginal infection
8. Any known allergies to D-mannose
18 Years
65 Years
ALL
No
Sponsors
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UCLH
UNKNOWN
University College, London
OTHER
Responsible Party
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Principal Investigators
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Jalesh Panicker, MD,FRCP
Role: PRINCIPAL_INVESTIGATOR
UCLH NHS Foundation Trust
Locations
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The National Hospital for Neurology and Neurosurgery
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Nakipoglu GF, Kaya AZ, Orhan G, Tezen O, Tunc H, Ozgirgin N, Ak F. Urinary dysfunction in multiple sclerosis. J Clin Neurosci. 2009 Oct;16(10):1321-4. doi: 10.1016/j.jocn.2008.12.012. Epub 2009 Jun 27.
de Seze M, Ruffion A, Denys P, Joseph PA, Perrouin-Verbe B; GENULF. The neurogenic bladder in multiple sclerosis: review of the literature and proposal of management guidelines. Mult Scler. 2007 Aug;13(7):915-28. doi: 10.1177/1352458506075651. Epub 2007 Mar 15.
The prevention and management of urinary tract infections among people with spinal cord injuries. National Institute on Disability and Rehabilitation Research Consensus Statement. January 27-29, 1992. J Am Paraplegia Soc. 1992 Jul;15(3):194-204. doi: 10.1080/01952307.1992.11735873.
Hoffman JM, Wadhwani R, Kelly E, Dixit B, Cardenas DD. Nitrite and leukocyte dipstick testing for urinary tract infection in individuals with spinal cord injury. J Spinal Cord Med. 2004;27(2):128-32. doi: 10.1080/10790268.2004.11753743.
Stohrer M, Blok B, Castro-Diaz D, Chartier-Kastler E, Del Popolo G, Kramer G, Pannek J, Radziszewski P, Wyndaele JJ. EAU guidelines on neurogenic lower urinary tract dysfunction. Eur Urol. 2009 Jul;56(1):81-8. doi: 10.1016/j.eururo.2009.04.028. Epub 2009 Apr 21.
Fowler CJ, Panicker JN, Drake M, Harris C, Harrison SC, Kirby M, Lucas M, Macleod N, Mangnall J, North A, Porter B, Reid S, Russell N, Watkiss K, Wells M. A UK consensus on the management of the bladder in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2009 May;80(5):470-7. doi: 10.1136/jnnp.2008.159178.
Leary SM, Porter B, Thompson AJ. Multiple sclerosis: diagnosis and the management of acute relapses. Postgrad Med J. 2005 May;81(955):302-8. doi: 10.1136/pgmj.2004.029413.
Hennessey A, Robertson NP, Swingler R, Compston DA. Urinary, faecal and sexual dysfunction in patients with multiple sclerosis. J Neurol. 1999 Nov;246(11):1027-32. doi: 10.1007/s004150050508.
Correale J, Fiol M, Gilmore W. The risk of relapses in multiple sclerosis during systemic infections. Neurology. 2006 Aug 22;67(4):652-9. doi: 10.1212/01.wnl.0000233834.09743.3b. Epub 2006 Jul 26.
Buljevac D, Flach HZ, Hop WC, Hijdra D, Laman JD, Savelkoul HF, van Der Meche FG, van Doorn PA, Hintzen RQ. Prospective study on the relationship between infections and multiple sclerosis exacerbations. Brain. 2002 May;125(Pt 5):952-60. doi: 10.1093/brain/awf098.
Rakusa M, Murphy O, McIntyre L, Porter B, Panicker J, Fowler C, Scott G, Chataway J. Testing for urinary tract colonization before high-dose corticosteroid treatment in acute multiple sclerosis relapses: prospective algorithm validation. Eur J Neurol. 2013 Mar;20(3):448-452. doi: 10.1111/j.1468-1331.2012.03806.x. Epub 2012 Jul 21.
Everaert K, Lumen N, Kerckhaert W, Willaert P, van Driel M. Urinary tract infections in spinal cord injury: prevention and treatment guidelines. Acta Clin Belg. 2009 Jul-Aug;64(4):335-40. doi: 10.1179/acb.2009.052.
Jepson RG, Williams G, Craig JC. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD001321. doi: 10.1002/14651858.CD001321.pub5.
Gallien 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.
Michaels EK, Chmiel JS, Plotkin BJ, Schaeffer AJ. Effect of D-mannose and D-glucose on Escherichia coli bacteriuria in rats. Urol Res. 1983;11(2):97-102. doi: 10.1007/BF00256954.
Kranjcec B, Papes D, Altarac S. D-mannose powder for prophylaxis of recurrent urinary tract infections in women: a randomized clinical trial. World J Urol. 2014 Feb;32(1):79-84. doi: 10.1007/s00345-013-1091-6. Epub 2013 Apr 30.
Compston A, Coles A. Multiple sclerosis. Lancet. 2002 Apr 6;359(9313):1221-31. doi: 10.1016/S0140-6736(02)08220-X.
Marrie RA, Cutter G, Tyry T, Vollmer T, Campagnolo D. Disparities in the management of multiple sclerosis-related bladder symptoms. Neurology. 2007 Jun 5;68(23):1971-8. doi: 10.1212/01.wnl.0000264416.53077.8b.
Phe V, Pakzad M, Haslam C, Gonzales G, Curtis C, Porter B, Chataway J, Panicker JN. Open label feasibility study evaluating D-mannose combined with home-based monitoring of suspected urinary tract infections in patients with multiple sclerosis. Neurourol Urodyn. 2017 Sep;36(7):1770-1775. doi: 10.1002/nau.23173. Epub 2016 Nov 4.
Other Identifiers
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14/0384
Identifier Type: -
Identifier Source: org_study_id
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