Cystitis RecurrentNCT05591742
Bacterial Composition and Recurrent Cystitis in Postmenopausal Women After Treatment With Lactobacilli.
A study testing FEMIDUR® in people with Cystitis Recurrent and Lactobacillus Infection, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cystitis Recurrent, Lactobacillus Infection
- What is being tested?
- FEMIDUR®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2021to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- vaginal prolapse with symptoms
- residual urine over 150 ml
- bladder diseases
- profylactic antibiotics
- probiotics
- bladder cancer
- genital cancer.
Trial locations and contacts
1 site in 1 country.
Louise TS Arenholt, Consultant contact
Denmark1 site, 1 recruiting
- Recruiting
AalborgH
Aalborg, Region Nord, 9000
Caroline Juhl, SR, 30287929, c.juhl@rn.dk
Louise TS Arenholt, Consultant, Itsa@rn.dk
About this study
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.
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:
Read more
- 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
- Being tested
- FEMIDUR®, Placebo Z Cap V-3 Pla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEMIDUR®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
Placebo Z Cap V-3 PlaOther
Consist mainly of maltodextrin. One tablet a day.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered. Receives: Other: Placebo Z Cap V-3 Pla |
| Femidur | Active comparator | As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered. Receives: Dietary Supplement: FEMIDUR® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
The micobiom will be analysed by 16s rRNA sequencing.
Measured: after study completion, an average of 1.5 year
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
Operational taxonomic unit (OTU) richness
Measured: after study completion, an average of 1.5 year
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
Shannon Index, as expression for the alpha diversity
Measured: after study completion, an average of 1.5 year
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
Beta diversity by means of PCA plots
Measured: after study completion, an average of 1.5 year
Secondary outcomes (9)
episodes of UTI
in numbers over time.
Measured: after study completion, an average of 2 months
changes in vaginal micobiome
The micobiom will be analysed by 16s rRNA sequencing.
Measured: after study completion, an average of 1.5 year
changes in vaginal micobiome
Operational taxonomic unit (OTU) richness
Measured: after study completion, an average of 1.5 year
changes in vaginal micobiome
Shannon Index, as expression for the alpha diversity
Measured: after study completion, an average of 1.5 year
changes in vaginal micobiome
Beta diversity by means of PCA plots
Measured: after study completion, an average of 1.5 year
Changes in fecal microbiome
The micobiom will be analysed by 16s rRNA sequencing.
Measured: after study completion, an average of 1.5 year
Changes in fecal microbiome
Operational taxonomic unit (OTU) richness
Measured: after study completion, an average of 1.5 year
Changes in fecal microbiome
Shannon Index, as expression for the alpha diversity
Measured: after study completion, an average of 1.5 year
Changes in fecal microbiome
Beta diversity by means of PCA plots
Measured: after study completion, an average of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start1 Oct 2021
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystitis RecurrentStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double blinded prospective, randomized cross-over study. Taking place over 6 months with 5 clinical visits.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Caroline S Juhl, Aalborg University Hospital
- Investigators
- Caroline S Juhl, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591742
- Sponsor's protocol ID
- N-20200092
- Status last verified
- Feb 2024
- First submitted
- 15 Oct 2022
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05591742
- Acronym / sponsor ID
- N-20200092
- Conditions
- Cystitis Recurrent, Lactobacillus Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blinded prospective, randomized cross-over study. Taking place over 6 months with 5 clinical visits.
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: Placebo Z Cap V-3 PlaAs it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered. |
| Femidur | Active comparator | Dietary Supplement: FEMIDUR®As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- vaginal prolapse with symptoms
- residual urine over 150 ml
- bladder diseases
- profylactic antibiotics
- probiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | Femidur |
| Placebo Z Cap V-3 PlaConsist mainly of maltodextrin. One tablet a day. | Other | placebo |
Primary outcome
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.
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
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
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
9 secondary outcomes
episodes of UTI
Time frame: after study completion, an average of 2 months
changes in vaginal micobiome
Time frame: after study completion, an average of 1.5 year
changes in vaginal micobiome
Time frame: after study completion, an average of 1.5 year
changes in vaginal micobiome
Time frame: after study completion, an average of 1.5 year
changes in vaginal micobiome
Time frame: after study completion, an average of 1.5 year
Changes in fecal microbiome
Time frame: after study completion, an average of 1.5 year
Changes in fecal microbiome
Time frame: after study completion, an average of 1.5 year
Changes in fecal microbiome
Time frame: after study completion, an average of 1.5 year
Changes in fecal microbiome
Time frame: after study completion, an average of 1.5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise TS Arenholt, Consultant contact
Caroline S Juhl principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FEMIDUR® in people with Cystitis Recurrent and Lactobacillus Infection, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline S Juhl, SR (0045 30287929, c.juhl@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.