Bacterial Composition and Recurrent Cystitis in Postmenopausal Women After Treatment With Lactobacilli.
- Conditions
- Cystitis RecurrentLactobacillus Infection
- Interventions
- Other: Placebo Z Cap V-3 PlaDietary Supplement: FEMIDUR®
- Registration Number
- NCT05591742
- Lead Sponsor
- Aalborg University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- 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
- vaginal prolapse with symptoms
- residual urine over 150 ml
- bladder diseases
- profylactic antibiotics
- probiotics
- bladder cancer
- genital cancer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description placebo Placebo Z Cap V-3 Pla As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered. Femidur FEMIDUR® As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered.
- Primary Outcome Measures
Name Time Method The change in the urine microbiome among postmenopausal women when treated with lactobacillis after study completion, an average of 1.5 year Beta diversity by means of PCA plots
- Secondary Outcome Measures
Name Time Method 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 Beta diversity by means of PCA plots
changes in vaginal micobiome after study completion, an average of 1.5 year Beta diversity by means of PCA plots
Trial Locations
- Locations (1)
AalborgH
🇩🇰Aalborg, Region Nord, Denmark