Bacterial Composition and Recurrent Cystitis in Postmenopausal Women After Treatment With Lactobacilli.

NCT05591742 | Recruiting

• 1 other identifier: N-20200092
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystitis Recurrent; Lactobacillus Infection

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (9)

• episodes of UTI

  after study completion, an average of 2 months

• changes in vaginal micobiome

  after study completion, an average of 1.5 year

• changes in vaginal micobiome

  after study completion, an average of 1.5 year

• changes in vaginal micobiome

  after study completion, an average of 1.5 year

• changes in vaginal micobiome

  after study completion, an average of 1.5 year

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Femidur

ACTIVE COMPARATOR

As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered.

Dietary Supplement: FEMIDUR®

Interventions

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

Femidur

Placebo Z Cap V-3 Pla OTHER

Consist mainly of maltodextrin. One tablet a day.

placebo

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: it can only be females with chromosome XX due to influence on hormones' and the length of urinary tract.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• vaginal prolapse with symptoms
• residual urine over 150 ml
• bladder diseases
• profylactic antibiotics
• probiotics
• bladder cancer
• genital cancer.

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg University: collaborator

Study Sites (1)

AalborgH

Aalborg, Region Nord, 9000, Denmark

RECRUITING

Study Officials

• Caroline S Juhl

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline S Juhl, SR

CONTACT

0045 30287929; c.juhl@rn.dk

Louise TS Arenholt, Consultant

CONTACT

ltsa@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All (participants, clinical staff, analyzers) are masked until all data have been analyzed.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior registrar

Model Details: double blinded prospective, randomized cross-over study. Taking place over 6 months with 5 clinical visits.

Study Record Dates

• First Submitted: October 15, 2022
• First Posted: October 24, 2022
• Study Start: October 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)