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

NCT05591742 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-05

No results posted yet for this study

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.

Conditions

  • Cystitis Recurrent
  • Lactobacillus Infection

Interventions

DIETARY_SUPPLEMENT

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

OTHER

Placebo Z Cap V-3 Pla

Consist mainly of maltodextrin. One tablet a day.

Sponsors & Collaborators

  • Aalborg University

    collaborator OTHER

  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Caroline S Juhl · Aalborg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-10-01
Completion
2025-10-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05591742 on ClinicalTrials.gov