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

Lactobacillus Infection Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05591742
• Other study ID #: N-20200092
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 1, 2025

Study information

• Verified date: February 2024
• Source: Aalborg University Hospital
• Contact: Caroline S Juhl, SR
• Phone: 0045 30287929
• Email: c.juhl[@]rn.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• vaginal prolapse with symptoms

• residual urine over 150 ml

• bladder diseases

• profylactic antibiotics

• probiotics

• bladder cancer

• genital cancer.

Related Conditions & MeSH terms

• Cystitis
• Cystitis Recurrent
• Lactobacillus Infection
• Recurrence

Intervention

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

Other:
• Placebo Z Cap V-3 Pla
Consist mainly of maltodextrin. One tablet a day.

Locations

Country	Name	City	State
Denmark	AalborgH	Aalborg	Region Nord

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University Hospital	Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	episodes of UTI	in numbers over time.	after study completion, an average of 2 months
Secondary	changes in vaginal micobiome	The micobiom will be analysed by 16s rRNA sequencing.	after study completion, an average of 1.5 year
Secondary	changes in vaginal micobiome	Operational taxonomic unit (OTU) richness	after study completion, an average of 1.5 year
Secondary	changes in vaginal micobiome	Shannon Index, as expression for the alpha diversity	after study completion, an average of 1.5 year
Secondary	changes in vaginal micobiome	Beta diversity by means of PCA plots	after study completion, an average of 1.5 year
Secondary	Changes in fecal microbiome	The micobiom will be analysed by 16s rRNA sequencing.	after study completion, an average of 1.5 year
Secondary	Changes in fecal microbiome	Operational taxonomic unit (OTU) richness	after study completion, an average of 1.5 year
Secondary	Changes in fecal microbiome	Shannon Index, as expression for the alpha diversity	after study completion, an average of 1.5 year
Secondary	Changes in fecal microbiome	Beta diversity by means of PCA plots	after study completion, an average of 1.5 year