Bacterial Composition and Recurrent Cystitis in Postmenopausal Women After Treatment With Lactobacilli.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2025-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystitis Recurrent Lactobacillus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

double blinded prospective, randomized cross-over study. Taking place over 6 months with 5 clinical visits.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

All (participants, clinical staff, analyzers) are masked until all data have been analyzed.

Study Groups

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placebo

As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered.

Group Type PLACEBO_COMPARATOR

Placebo Z Cap V-3 Pla

Intervention Type OTHER

Consist mainly of maltodextrin. One tablet a day.

Femidur

As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered.

Group Type ACTIVE_COMPARATOR

FEMIDUR®

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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FEMIDUR®

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

Intervention Type DIETARY_SUPPLEMENT

Placebo Z Cap V-3 Pla

Consist mainly of maltodextrin. One tablet a day.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes