Cystitis Recurrent, Lactobacillus Infection
Conditions
Brief summary
The goal of this clinical trial is to learn about the effect on the bacterial composition in the microbiome (the body's own bacteria) of urine, vagina and faeces after treatment with lactobacilli (lactobacilli's are a part of the microbiome), and its influence on repeated cystitis in postmenopausal women. The main questions it aims to answer are: * Does treatment with lactobacilli change the composition of the urine microbiome in postmenopausal women? * Does treatment with lactobacilli prevent repeated cystitis in postmenopausal women? Participants will be followed for 6 months. They will for 3 months receive a look-alike substance that contains no active drug and for the other 3 months tablets with lactobacilli. A computer program will decide what treatment the participant will begin with, and after 3 months she will be receiving the tablets, she did not get first. This way all participants receive both type of tablets and can be their own control. What type of tablet the participants is taking is unknown to both clinical staff and participants. The participants will come to the hospital for start-up, and every 1,5 moths for the next 6 months. They deliver * faeces sample * urine tests * vaginal swab each time they are seen. When entering the study, they also complete health care questions on medication, earlier surgery, alcohol, tobacco, childbirths, weight, height etc. They make a drinking and voiding diary 3 times over the 6 months. When the study is over, alle the samples of faeces, urine and the vaginal swab will undergo analyzation for the bacterial composition in the microbiome, and differences in the microbiome when taking lactobacilli or not will be examined. The urine sample is controlled for bacteria known to give cystitis, and the influence on repeated cystitis will also be examined.
Interventions
OTHERPlacebo Z Cap V-3 Pla
Consist mainly of maltodextrin. One tablet a day.
DIETARY_SUPPLEMENTFEMIDUR®
Femidur® consist of 2 vaginal lactobacillis; Lactobacillus rhamnosus GR-1® and Lactobacillus reuteri RC-14®. One tablet a day. Placebo Z Cap V-3 Pla; mainly maltodextrin
Sponsors
Aalborg University
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All (participants, clinical staff, analyzers) are masked until all data have been analyzed.
Intervention model description
double blinded prospective, randomized cross-over study. Taking place over 6 months with 5 clinical visits.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* postmenopausal women * if hysterectomy before menopause, then age of \>60 years * verified diagnose of recurrent cystitis. (two in 6 months or 3 in a year, verified by cultivation) * able to speak and write Danish
Exclusion criteria
* vaginal prolapse with symptoms * residual urine over 150 ml * bladder diseases * profylactic antibiotics * probiotics * bladder cancer * genital cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in the urine microbiome among postmenopausal women when treated with lactobacillis | after study completion, an average of 1.5 year | The micobiom will be analysed by 16s rRNA sequencing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in vaginal micobiome | after study completion, an average of 1.5 year | The micobiom will be analysed by 16s rRNA sequencing. |
| episodes of UTI | after study completion, an average of 2 months | in numbers over time. |
| Changes in fecal microbiome | after study completion, an average of 1.5 year | The micobiom will be analysed by 16s rRNA sequencing. |
Countries
Denmark
Contacts
Primary ContactCaroline S Juhl, SR
Backup ContactLouise TS Arenholt, Consultant
Outcome results
None listed