Clinical trial NCT05591742: Bacterial Composition and Recurrent Cystitis in Postmenopausal Women After Treatment With Lactobacilli.
Official title: The Effect on Bacterial Composition in Urine, Vagina and Faces After Treatment With Lactobacilli and Its Influence on Recurrent Cystitis in Postmenopausal Women.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cystitis Recurrent
Lactobacillus Infection
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2022-10-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: double blinded prospective, randomized cross-over study. Taking place over 6 months with 5 clinical visits.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The change in the urine microbiome among postmenopausal women when treated with lactobacillis
timeFrame: after study completion, an average of 1.5 year
measure: The change in the urine microbiome among postmenopausal women when treated with lactobacillis
timeFrame: after study completion, an average of 1.5 year
measure: The change in the urine microbiome among postmenopausal women when treated with lactobacillis
timeFrame: after study completion, an average of 1.5 year
measure: The change in the urine microbiome among postmenopausal women when treated with lactobacillis
timeFrame: after study completion, an average of 1.5 year
Secondary outcomes:
measure: episodes of UTI
timeFrame: after study completion, an average of 2 months
measure: changes in vaginal micobiome
timeFrame: after study completion, an average of 1.5 year
measure: changes in vaginal micobiome
timeFrame: after study completion, an average of 1.5 year
measure: changes in vaginal micobiome
timeFrame: after study completion, an average of 1.5 year
measure: changes in vaginal micobiome
timeFrame: after study completion, an average of 1.5 year
measure: Changes in fecal microbiome
timeFrame: after study completion, an average of 1.5 year
measure: Changes in fecal microbiome
timeFrame: after study completion, an average of 1.5 year
measure: Changes in fecal microbiome
timeFrame: after study completion, an average of 1.5 year
measure: Changes in fecal microbiome
timeFrame: after study completion, an average of 1.5 year
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: AalborgH
state: Region Nord
Study officials:
affiliation: Aalborg University Hospital
name: Caroline S Juhl
role: PRINCIPAL_INVESTIGATOR
References: