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

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Description

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 Overview

Start Date
October 1, 2021
Completion Date
October 1, 2025
Enrollment
100
Date Posted
October 24, 2022
Accepts Healthy Volunteers?
Yes
Gender
Female

Locations

Full Address
AalborgH
Aalborg, Region Nord 9000, Denmark

Eligibility

Minimum Age (years)
50
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.

Study Contact Info

Study Contact Name
Caroline S Juhl, SR; Louise TS Arenholt, Consultant
Study Contact Email
Study Contact Phone

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05591742