An interventional study of FEMIDUR® and Placebo Z Cap V-3 Pla in Cystitis Recurrent and Lactobacillus Infection, sponsored by Aalborg University Hospital. Recruiting at 1 site in Denmark. Open to female participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-05.
Sponsored by Aalborg University Hospital · Not applicable, Interventional, and Treatment
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.
69 studies on the registry are indexed under Cystitis; 17 are open to participants now.
This study's planned enrollment of 100 is below the median of 112 across 50 interventional studies indexed under Cystitis.
Browse Cystitis studies →Aalborg University Hospital is the lead sponsor of 198 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered.
Other: Placebo Z Cap V-3 Pla
As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered.
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
Consist mainly of maltodextrin. One tablet a day.
The change in the urine microbiome among postmenopausal women when treated with lactobacillis
The micobiom will be analysed by 16s rRNA sequencing.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: after study completion, an average of 1.5 year
episodes of UTI
in numbers over time.
Time frame: after study completion, an average of 2 months
changes in vaginal micobiome
The micobiom will be analysed by 16s rRNA sequencing.
Time frame: after study completion, an average of 1.5 year
changes in vaginal micobiome
Operational taxonomic unit (OTU) richness
Time frame: after study completion, an average of 1.5 year
changes in vaginal micobiome
Shannon Index, as expression for the alpha diversity
Time frame: after study completion, an average of 1.5 year
changes in vaginal micobiome
Beta diversity by means of PCA plots
Time frame: after study completion, an average of 1.5 year
Changes in fecal microbiome
The micobiom will be analysed by 16s rRNA sequencing.
Time frame: after study completion, an average of 1.5 year
Changes in fecal microbiome
Operational taxonomic unit (OTU) richness
Time frame: after study completion, an average of 1.5 year
Changes in fecal microbiome
Shannon Index, as expression for the alpha diversity
Time frame: after study completion, an average of 1.5 year
Changes in fecal microbiome
Beta diversity by means of PCA plots
Time frame: after study completion, an average of 1.5 year
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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