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D-mannose for the Prevention of UTIs in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02490046
Recruitment Status : Unknown
Verified July 2015 by University College, London.
Recruitment status was:  Recruiting
First Posted : July 3, 2015
Last Update Posted : July 3, 2015
Sponsor:
Collaborator:
UCLH
Information provided by (Responsible Party):
University College, London

Study Description
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Brief Summary:

This is a study to explore the feasibility of using D-mannose, a commonly used food supplement, in persons with multiple sclerosis reporting recurrent urinary tract infections. Twenty persons with multiple sclerosis (10 patients using catheters and 10 not using catheters) reporting recurrent urinary tract infections will receive D-mannose 1.5 grams twice daily for 16 weeks duration.

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Recurrent Urinary Tract Infections Dietary Supplement: D Mannose Phase 1

Detailed Description:

Informed consent procedure: Potential participants will be approached in clinic and given a patient information sheet and adequate time will be given for the individual to read through the patient information sheet and for clarification of any queries or concerns. Informed consent will be obtained by one of the investigators involved in the conduct of the study prior to participation in the trial, following adequate explanation of the aims, methods, anticipated benefits and potential hazards of the study.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Single Centre Open-label Feasibility Study Evaluating the Use of D-mannose in Multiple Sclerosis
Study Start Date : February 2015
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Dietary Supplement: 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.
Experimental: 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
 Dietary Supplement: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Compliance (self-usage diary and weight of returned containers of D-mannose) [ Time Frame: 16 weeks ]
    Compliance to a 16-week course of D-mannose as assessed using a self-usage diary and weight of returned containers of D-mannose. The number of days the participant does not use D-mannose and reasons for non-use will be noted.


Secondary Outcome Measures :
  1. Antibiotic prescription (Number of prescriptions for antibiotics required) [ Time Frame: 16 weeks ]
    Number of prescriptions for antibiotics required during the 16-week course


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a known diagnosis of Multiple sclerosis (all stages) who have been clinically stable for at least three months and reporting lower urinary tract symptoms.
  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:

  1. Pregnancy or planning pregnancy
  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490046


Contacts
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Contact: Jalesh Panicker, MD, FRCP 0203 448 4713 j.panicker@ucl.ac.uk
Contact: Véronique Phé, MD 0203 448 4713 Veronique.Phe@uclh.nhs.uk

Locations
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United Kingdom
The National Hospital for Neurology and Neurosurgery Recruiting
London, United Kingdom, WC1N 3BG
Contact: Jalesh Panicker, MD, FRCP    020 344 84713    j.panicker@ucl.ac.uk   
Contact: Véronique Phé, MD    020 344 84713    Veronique.Phe@uclh.nhs.uk   
Sub-Investigator: Mahreen Pakzad, FRCS         
Principal Investigator: Jalesh Panicker, MD, FRCP         
Sub-Investigator: Véronique Phé, MD         
Sponsors and Collaborators
University College, London
UCLH
Investigators
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Principal Investigator: Jalesh Panicker, MD,FRCP UCLH NHS Foundation Trust
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02490046    
Other Study ID Numbers: 14/0384
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015
Keywords provided by University College, London:
D mannose
multiple sclerosis
recurrent urinary infections
Additional relevant MeSH terms:
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Urinary Tract Infections
Multiple Sclerosis
Sclerosis
Infections
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Urologic Diseases