Ignite Creation Date:
2024-05-06 @ 7:12 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02490046
Status:
UNKNOWN
Last Update Posted:
2015-07-03
First Post:
2015-04-28
Brief Title:
D-mannose for the Prevention of UTIs in Multiple Sclerosis
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
Single Centre Open-label Feasibility Study Evaluating the Use of D-mannose in Multiple Sclerosis
Status:
UNKNOWN
Status Verified Date:
2015-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 15 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
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 15 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
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 15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None