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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 August 2015 |
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Main ID: |
NCT02490046 |
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Date of registration:
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28/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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D-mannose for the Prevention of UTIs in Multiple Sclerosis
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Scientific title:
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Single Centre Open-label Feasibility Study Evaluating the Use of D-mannose in Multiple Sclerosis |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02490046 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 1
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Jalesh Panicker, MD,FRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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UCLH NHS Foundation Trust |
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Name:
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Jalesh Panicker, MD, FRCP |
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Address:
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Telephone:
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0203 448 4713 |
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Email:
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j.panicker@ucl.ac.uk |
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Affiliation:
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Name:
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Jalesh Panicker, MD, FRCP |
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Address:
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Telephone:
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020 344 84713 |
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Email:
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j.panicker@ucl.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Recurrent Urinary Tract Infections
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Intervention(s)
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Dietary Supplement: D Mannose
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Primary Outcome(s)
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Compliance (self-usage diary and weight of returned containers of D-mannose)
[Time Frame: 16 weeks]
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Secondary Outcome(s)
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Antibiotic prescription (Number of prescriptions for antibiotics required)
[Time Frame: 16 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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