Bacterial Composition and Recurrent Cystitis in Postmenopausal Women After Treatment With Lactobacilli.
Primary Purpose
Cystitis Recurrent, Lactobacillus Infection
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
FEMIDUR®
Placebo Z Cap V-3 Pla
Sponsored by
About this trial
This is an interventional treatment trial for Cystitis Recurrent
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.
Sites / Locations
- AalborgHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
Femidur
Arm Description
As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered.
As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered.
Outcomes
Primary Outcome Measures
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
The micobiom will be analysed by 16s rRNA sequencing.
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
Operational taxonomic unit (OTU) richness
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
Shannon Index, as expression for the alpha diversity
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
Beta diversity by means of PCA plots
Secondary Outcome Measures
episodes of UTI
in numbers over time.
changes in vaginal micobiome
The micobiom will be analysed by 16s rRNA sequencing.
changes in vaginal micobiome
Operational taxonomic unit (OTU) richness
changes in vaginal micobiome
Shannon Index, as expression for the alpha diversity
changes in vaginal micobiome
Beta diversity by means of PCA plots
Changes in fecal microbiome
The micobiom will be analysed by 16s rRNA sequencing.
Changes in fecal microbiome
Operational taxonomic unit (OTU) richness
Changes in fecal microbiome
Shannon Index, as expression for the alpha diversity
Changes in fecal microbiome
Beta diversity by means of PCA plots
Full Information
NCT ID
NCT05591742
First Posted
October 15, 2022
Last Updated
October 19, 2022
Sponsor
Aalborg University Hospital
Collaborators
Aalborg University
1. Study Identification
Unique Protocol Identification Number
NCT05591742
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
Collaborators
Aalborg University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis Recurrent, Lactobacillus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
double blinded prospective, randomized cross-over study. Taking place over 6 months with 5 clinical visits.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All (participants, clinical staff, analyzers) are masked until all data have been analyzed.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered.
Arm Title
Femidur
Arm Type
Active Comparator
Arm Description
As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered.
Intervention Type
Dietary Supplement
Intervention Name(s)
FEMIDUR®
Intervention Description
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
Other
Intervention Name(s)
Placebo Z Cap V-3 Pla
Intervention Description
Consist mainly of maltodextrin. One tablet a day.
Primary Outcome Measure Information:
Title
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
Description
The micobiom will be analysed by 16s rRNA sequencing.
Time Frame
after study completion, an average of 1.5 year
Title
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
Description
Operational taxonomic unit (OTU) richness
Time Frame
after study completion, an average of 1.5 year
Title
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
Description
Shannon Index, as expression for the alpha diversity
Time Frame
after study completion, an average of 1.5 year
Title
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
Description
Beta diversity by means of PCA plots
Time Frame
after study completion, an average of 1.5 year
Secondary Outcome Measure Information:
Title
episodes of UTI
Description
in numbers over time.
Time Frame
after study completion, an average of 2 months
Title
changes in vaginal micobiome
Description
The micobiom will be analysed by 16s rRNA sequencing.
Time Frame
after study completion, an average of 1.5 year
Title
changes in vaginal micobiome
Description
Operational taxonomic unit (OTU) richness
Time Frame
after study completion, an average of 1.5 year
Title
changes in vaginal micobiome
Description
Shannon Index, as expression for the alpha diversity
Time Frame
after study completion, an average of 1.5 year
Title
changes in vaginal micobiome
Description
Beta diversity by means of PCA plots
Time Frame
after study completion, an average of 1.5 year
Title
Changes in fecal microbiome
Description
The micobiom will be analysed by 16s rRNA sequencing.
Time Frame
after study completion, an average of 1.5 year
Title
Changes in fecal microbiome
Description
Operational taxonomic unit (OTU) richness
Time Frame
after study completion, an average of 1.5 year
Title
Changes in fecal microbiome
Description
Shannon Index, as expression for the alpha diversity
Time Frame
after study completion, an average of 1.5 year
Title
Changes in fecal microbiome
Description
Beta diversity by means of PCA plots
Time Frame
after study completion, an average of 1.5 year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
it can only be females with chromosome XX due to influence on hormones' and the length of urinary tract.
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline S Juhl, SR
Phone
0045 30287929
Email
c.juhl@rn.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Louise TS Arenholt, Consultant
Email
ltsa@rn.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline S Juhl
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AalborgH
City
Aalborg
State/Province
Region Nord
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Juhl, SR
Phone
30287929
Email
c.juhl@rn.dk
First Name & Middle Initial & Last Name & Degree
Louise TS Arenholt, Consultant
Email
Itsa@rn.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bacterial Composition and Recurrent Cystitis in Postmenopausal Women After Treatment With Lactobacilli.
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