Single Centre Open-label Feasibility Study Evaluating the Use of D-mannose in Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Compliance (self-usage diary and weight of returned containers of D-mannose)
研究概览
简要总结
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:
- Assessing compliance to a 16-week course of D-mannose
- Quantifying the number of prescriptions for antibiotics during the 16 weeks course of D-mannose
详细描述
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™).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
- •Age over 18 years and below 65
- •Females of childbearing potential using effective contraception if sexually active - oral contraceptive pill (> 3 months use), condoms, intrauterine contraceptive device, depot injection
排除标准
- •Pregnancy or planning pregnancy
- •Breastfeeding
- •History of congenital urinary tract anomalies or interstitial cystitis
- •History of diabetes mellitus
- •Receiving antibiotic prophylaxis or cranberry extract preparations
- •Current urinary tract infection
- •Current vaginal infection
- •Any known allergies to D-mannose
研究组 & 干预措施
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
干预措施: D Mannose (Dietary Supplement)
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
干预措施: D Mannose (Dietary Supplement)
结局指标
主要结局
Compliance (self-usage diary and weight of returned containers of D-mannose)
时间窗: 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.
次要结局
- Antibiotic prescription (Number of prescriptions for antibiotics required)(16 weeks)