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| Name | Class |
|---|---|
| Aalborg University | OTHER |
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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:
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered. |
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| Femidur | Active Comparator | As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The change in the urine microbiome among postmenopausal women when treated with lactobacillis | 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 | 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 | 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 | Beta diversity by means of PCA plots | after study completion, an average of 1.5 year |
| Measure | Description | Time Frame |
|---|---|---|
| episodes of UTI | in numbers over time. | after study completion, an average of 2 months |
| changes in vaginal micobiome | The micobiom will be analysed by 16s rRNA sequencing. |
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Inclusion Criteria:
Exclusion Criteria:
it can only be females with chromosome XX due to influence on hormones' and the length of urinary tract.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline S Juhl, SR | Contact | 0045 30287929 | c.juhl@rn.dk | |
| Louise TS Arenholt, Consultant | Contact | ltsa@rn.dk |
| Name | Affiliation | Role |
|---|---|---|
| Caroline S Juhl | Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AalborgH | Recruiting | Aalborg | Region Nord | 9000 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2022 | Oct 19, 2022 | Prot_SAP_000.pdf |
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double blinded prospective, randomized cross-over study. Taking place over 6 months with 5 clinical visits.
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All (participants, clinical staff, analyzers) are masked until all data have been analyzed.
| Placebo Z Cap V-3 Pla | Other | Consist mainly of maltodextrin. One tablet a day. |
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| after study completion, an average of 1.5 year |
| changes in vaginal micobiome | Operational taxonomic unit (OTU) richness | after study completion, an average of 1.5 year |
| changes in vaginal micobiome | Shannon Index, as expression for the alpha diversity | after study completion, an average of 1.5 year |
| changes in vaginal micobiome | Beta diversity by means of PCA plots | after study completion, an average of 1.5 year |
| Changes in fecal microbiome | The micobiom will be analysed by 16s rRNA sequencing. | after study completion, an average of 1.5 year |
| Changes in fecal microbiome | Operational taxonomic unit (OTU) richness | after study completion, an average of 1.5 year |
| Changes in fecal microbiome | Shannon Index, as expression for the alpha diversity | after study completion, an average of 1.5 year |
| Changes in fecal microbiome | Beta diversity by means of PCA plots | after study completion, an average of 1.5 year |