Bacterial Composition and Recurrent Cystitis in Postmenopausal Women After Treatment With Lactobacilli.
The Effect on Bacterial Composition in Urine, Vagina and Faces After Treatment With Lactobacilli and Its Influence on Recurrent Cystitis in Postmenopausal Women.
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Caroline S Juhl, SR
- Phone Number: 0045 30287929
- Email: c.juhl@rn.dk
Study Contact Backup
- Name: Louise TS Arenholt, Consultant
- Email: ltsa@rn.dk
Study Locations
-
-
Region Nord
-
Aalborg, Region Nord, Denmark, 9000
- Recruiting
- AalborgH
-
Contact:
- Caroline Juhl, SR
- Phone Number: 30287929
- Email: c.juhl@rn.dk
-
Contact:
- Louise TS Arenholt, Consultant
- Email: Itsa@rn.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: placebo
As it is blinded, no one knows which arm participants enter.
After 3 months the other arm is entered.
|
Consist mainly of maltodextrin.
One tablet a day.
|
|
Active Comparator: Femidur
As it is blinded, no one knows which arm participants enter.
After 3 months the other arm is entered.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
after study completion, an average of 1.5 year
|
|
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
Time Frame: after study completion, an average of 1.5 year
|
Operational taxonomic unit (OTU) richness
|
after study completion, an average of 1.5 year
|
|
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
Time Frame: after study completion, an average of 1.5 year
|
Shannon Index, as expression for the alpha diversity
|
after study completion, an average of 1.5 year
|
|
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
Time Frame: after study completion, an average of 1.5 year
|
Beta diversity by means of PCA plots
|
after study completion, an average of 1.5 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
episodes of UTI
Time Frame: after study completion, an average of 2 months
|
in numbers over time.
|
after study completion, an average of 2 months
|
|
changes in vaginal micobiome
Time Frame: after study completion, an average of 1.5 year
|
The micobiom will be analysed by 16s rRNA sequencing.
|
after study completion, an average of 1.5 year
|
|
changes in vaginal micobiome
Time Frame: after study completion, an average of 1.5 year
|
Operational taxonomic unit (OTU) richness
|
after study completion, an average of 1.5 year
|
|
changes in vaginal micobiome
Time Frame: after study completion, an average of 1.5 year
|
Shannon Index, as expression for the alpha diversity
|
after study completion, an average of 1.5 year
|
|
changes in vaginal micobiome
Time Frame: after study completion, an average of 1.5 year
|
Beta diversity by means of PCA plots
|
after study completion, an average of 1.5 year
|
|
Changes in fecal microbiome
Time Frame: after study completion, an average of 1.5 year
|
The micobiom will be analysed by 16s rRNA sequencing.
|
after study completion, an average of 1.5 year
|
|
Changes in fecal microbiome
Time Frame: after study completion, an average of 1.5 year
|
Operational taxonomic unit (OTU) richness
|
after study completion, an average of 1.5 year
|
|
Changes in fecal microbiome
Time Frame: after study completion, an average of 1.5 year
|
Shannon Index, as expression for the alpha diversity
|
after study completion, an average of 1.5 year
|
|
Changes in fecal microbiome
Time Frame: after study completion, an average of 1.5 year
|
Beta diversity by means of PCA plots
|
after study completion, an average of 1.5 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Caroline S Juhl, Aalborg University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-20200092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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