The Effect on Bacterial Composition in Urine, Vagina and Faces After Treatment With Lactobacilli and Its Influence on Recurrent Cystitis in Postmenopausal Women.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Aalborg University Hospital
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- The change in the urine microbiome among postmenopausal women when treated with lactobacillis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
All (participants, clinical staff, analyzers) are masked until all data have been analyzed.
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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.
Outcomes
Primary Outcomes
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
Time Frame: after study completion, an average of 1.5 year
The micobiom will be analysed by 16s rRNA sequencing.
Secondary Outcomes
- Changes in fecal microbiome(after study completion, an average of 1.5 year)
- episodes of UTI(after study completion, an average of 2 months)
- changes in vaginal micobiome(after study completion, an average of 1.5 year)
Investigators
Caroline S Juhl
Senior registrar
Aalborg University Hospital