Clinical trial NCT02490046: D-mannose for the Prevention of UTIs in Multiple Sclerosis
Official title: Single Centre Open-label Feasibility Study Evaluating the Use of D-mannose in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Multiple Sclerosis
Recurrent Urinary Tract Infections
Keywords: D mannose
multiple sclerosis
recurrent urinary infections
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: UCLH
First posted: 2015-07-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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.

Eligibility 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

Primary outcomes:
measure: Compliance (self-usage diary and weight of returned containers of D-mannose)
timeFrame: 16 weeks
Secondary outcomes:
measure: Antibiotic prescription (Number of prescriptions for antibiotics required)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The National Hospital for Neurology and Neurosurgery
Study officials:
affiliation: UCLH NHS Foundation Trust
name: Jalesh Panicker, MD,FRCP
role: PRINCIPAL_INVESTIGATOR
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