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

Aalborg University Hospital

Status: Enrolling

Conditions: Lactobacillus Infection; Cystitis Recurrent

Treatments: Other: Placebo Z Cap V-3 Pla; Dietary Supplement: FEMIDUR®

Study type: Interventional

Funder types: Other

Identifiers

NCT05591742

N-20200092

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo Z Cap V-3 Pla

Femidur

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: FEMIDUR®