D-mannose for the Prevention of UTIs in Multiple Sclerosis

July 1, 2015 updated by: University College, London

Single Centre Open-label Feasibility Study Evaluating the Use of D-mannose in Multiple Sclerosis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 3BG
        • Recruiting
        • The National Hospital for Neurology and Neurosurgery
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Mahreen Pakzad, FRCS
        • Principal Investigator:
          • Jalesh Panicker, MD, FRCP
        • Sub-Investigator:
          • Véronique Phé, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic prescription (Number of prescriptions for antibiotics required)
Time Frame: 16 weeks
Number of prescriptions for antibiotics required during the 16-week course
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

UCLH

Investigators

  • Principal Investigator: Jalesh Panicker, MD,FRCP, UCLH NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 3, 2015

Study Record Updates

Last Update Posted (Estimate)

July 3, 2015

Last Update Submitted That Met QC Criteria

July 1, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/0384

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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