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NCT05591742
Bacterial Composition and Recurrent Cystitis in Postmenopausal Women After Treatment With Lactobacilli.
NA trial testing FEMIDUR® in Cystitis Recurrent in 100 participants. Status unknown.
1 October 2024
Quick facts
| Lead sponsor | Aalborg University Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 October 2021 |
| Primary completion | 1 October 2024 |
| Estimated completion | 1 October 2025 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- FEMIDUR®
- Placebo Z Cap V-3 Pla
Conditions studied
- Cystitis Recurrent — all drugs for Cystitis Recurrent →
- Lactobacillus Infection — all drugs for Lactobacillus Infection →
Sponsor
Aalborg University Hospital
Who can join
50 and older, female only, with Cystitis Recurrent or Lactobacillus Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05591742
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cystitis Recurrent
Currently open trials in the same condition.
- NCT06907199 — Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for Women With Recurrent Urinary Tract Infecti · Phase 1 · recruiting
- NCT06940622 — A Trial of D-mannose for the Prophylaxis of Recurrent Urinary Tract Infections · NA · recruiting
- NCT04747041 — Evaluation of a Phyto Aromatherapy Treatment in the Management of Recurrent Cystitis · NA · active not recruiting
Other Aalborg University Hospital trials
Trials by the same sponsor.
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- NCT07165574 — Prevalence of Anticholinergics in Geriatric Patients With Acute Functional Deterioration · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05591742 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aalborg University Hospital
- Last refreshed: 5 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05591742.
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