It is hypothesized that the multi-species probiotic formulation Winclove CLEAR may reduce the incidence- and symptom severity of urinary tract infections in women and thus improve patient quality of life
ID
Bron
Verkorte titel
Aandoening
(Recurrent) Urinary Tract Infections / (Recidiverende) Urineweginfecties
Cystitis / Cystitis
Quality of Life / Levenskwaliteit
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. The differences in QoL between treatment arms according
to UTI-QoL-questionnaire data and SF-36 scores after the
intervention period.<br>
2. The difference in UTI incidence between treatment arms,
as measured by the mean number of patient-reported UTI
episodes during the intervention period.<br>
3. The difference in UTI symptom severity between
treatment arms, as measured by mean Symptom & Burden
questionnaire scores during the intervention period.
Achtergrond van het onderzoek
Urinary tract infections (UTIs) have an inimical influence on patient quality of life (QoL) and over a third of patients are likely to develop recurrent UTIs (rUTI) within the next twelve months. Women in particular, as they are substantially more susceptible to infection than men. Currently, few effective prevention (or treatment) options for UTI exist, other than prophylactic antibiotics. The adverse effects associated with repeated use of antimicrobial prophylaxis pose an additional burden on patient QoL (e.g. Antibiotic Associated Diarrhoea or vaginal candidiasis). Moreover, antibiotic effectiveness is diminishing due to increasing antimicrobial resistance. Such resistance makes UTIs increasingly difficult to treat. The current needs of rUTI patients are therefore unmet and require new nonantibiotic treatment/prevention options. A growing body of evidence suggest that probiotics may protect against urogenital infections, among which UTIs. A new multispecies probiotic formulation for the prevention of UTI (Winclove CLEAR) has therefore been developed recently. Winclove CLEAR is developed to support the host and prevent pathogens from migrating to the bladder. It is suggested that the probiotic strains of Winclove CLEAR may prevent UTIs through local competition with uropathogens and through the production of antibacterial agents. It is therefore hypothesized that the probiotic formulation may reduce the incidence- and symptom severity of UTIs and improve patient QoL.
Doel van het onderzoek
It is hypothesized that the multi-species probiotic formulation Winclove CLEAR may reduce the incidence- and symptom severity of urinary tract infections in women and thus improve patient quality of life
Onderzoeksopzet
T0, Visit 1, Day 0.
- Informed Consent, Screening, Questionnaires, Urine Sample, Treatment Administration.
T1, Visit 2, Day 60.
- Questionnaires, Urine Sample.
T2, Visit 3, Day 120.
- Questionnaires, Urine Sample.
T3, Visit 4, Day 180.
- Questionnaires, Urine Sample, Treatment Seized. End of study.
Onderzoeksproduct en/of interventie
In this two-armed clinical trial, participants will be randomized (1:1) to either Winclove CLEAR or matching placebo.
- Active treatment: Participants (N = 20) consume a daily dose of 4g of Winclove CLEAR containing 4E+09 CFU of live probiotic strains L. pentosus W2 (KCA1), L. acidophilus W22, L. plantarum W21, L. salivarius W24, L. brevis W63, L. casei W56 and L. helveticus W74, cranberry extract (36 mg PACs) and D-mannose (1g) for a period of 6 consecutive months.
- Placebo: Participants (N = 20) consume a daily dose of 4g of the placebo formulation, similar in taste/smell/appearance but without active ingredients (e.g. probiotic, cranberry, D-mannose), for a period of 6 consecutive months.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible for inclusion, a subject must meet all
of the following criteria:
1. rUTI* for at least 2 years (defined as 3 or more episodes
of UTI per year).
2. At least 3 UTIs in the preceding 12 months.
3. Aged between 18 and 70 years.
4. Willing to take probiotics and refrain from UTI prophylaxis
during the study.
5. Signed informed consent.
* (Recurrent) Urinary Tract Infections
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be
excluded from participation in this study:
1. Current (complicated) suspected UTI or cystitis
2. Prophylactic antibiotic usage during the intervention period
3. Probiotic, D-mannose or cranberry extract usage during the
intervention period
4. Use of UTI prophylactics/treatments during the intervention
period, other than mentioned under point 2 & 3, which in the
opinion of the investigator may significantly interfere with the
evaluation of the study objectives, including: estrogen treatment,
immunoprophylaxis, methenamine Hippurate, ascorbic acid
supplementation, acupuncture, UTI specific vaccines and
endovesical instillation (of hyaluronic acid and chondroitin
sulphate)*.
5. Concurrently enrolled in another intervention study
(observational studies or inclusion following completion of another
study is allowed (4-week wash-out))
6. Known to have interstitial cystitis or bladder pain syndrome
7. Known to have a complex bladder disturbance (e.g.
cystoplasty, renal and bladder calculus, significant hydronephrosis
or current pyelonephritis)
8. Known to have severe renal or hepatic failure
9. Known to be severely or terminally ill
10. Known to have non-resolvable urinary obstruction
11. Known to have a history of adverse drug reaction to yoghurt or
milk products or a demonstrated intolerance to the probiotics used
- lactose intolerance is NOT an exclusion criterion
12. Known to be intolerant or allergic to any of the ingredients in
both Winclove CLEAR and matched placebo
13. Spinal cord injury with suprapubic permanent catheter
14. Requiring full (invasive) mechanical ventilation
15. Receiving immunosuppressant medications or having an
underlying immunosuppressive disease (e.g. HIV, end-stage /
progressive diabetes mellitus, multiple sclerosis or
cerebrovascular disease)
16. Planned oral/vaginal/urinary tract/bladder/gastrointestinal
surgery during the intervention period
17. Recent oral/vaginal/urinary tract/bladder
surgery/gastrointestinal (within last 3 months)
18. Pregnant females (screened with a positive pregnancy test),
lactating or intending to become pregnant during the study.
Women of childbearing potential need to use contraceptives
19. Use of intravaginal products (e.g. spermicides) except for
menstrual products.
20. Any other condition, which, in the opinion of the investigator,
may significantly interfere with the evaluation of the study
objectives
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6832 |
| NTR-old | NTR7069 |
| CCMO | NL64708.072.18 |
| OMON | NL-OMON46636 |