Analysis of Urinary, Vaginal and Intestinal Microbiota in Patients With Neurogenic Bladder

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06093035
Collaborator
(none)
60
13.7

Study Details

Study Description

Brief Summary

The neurogenic bladder and bowel are two pathological conditions occurring when damaged innervation results in functional alteration of both the bladder and the bowel with a clinical presentation that can vary from retention to incontinence often associated with an increased risk of infection. Specific microbiological patterns of urinary microbiota are associated with states of well-being of the host and play protective and preventive functions for numerous urological pathologies such as urinary tract infections, urinary incontinence and bladder tumors. What the "healthy" profile of the bladder microbiota is in subjects with neurogenic bladder appears currently poorly reported in literature data. Indeed, in these populations different strains of uropathogenic microorganisms, such as E.Coli, Klebsiella, Pseudomonas and Enterococcus, are dominant compared to healthy subjects where Lactobacillus predominates. The characterization of the gut microbiota in terms of composition can be a key tool for understanding the effects that preventive therapeutic and nutritional approaches or clinical procedures have on it, subsequently offering the possibility of improving and complementing these treatments.

Among human microbiota, the vaginal one, the "vaginoma", is among the most studied for its correlation with female health status. The "core" of the vaginal microbiome is Lactobacillus which under physiological conditions is represented in particular by Lactobacillus Crispatus, Lactobacillus Iners, Lactobacillus Jensenii and Lactobacillus Gasseri. Immune cells and related PRRs receptors interact with the microorganisms in the vaginal environment of the vaginal environment are the immune cells and the related PRRs receptors thus the close relationship between microbiome and immunity as well as between vaginoma and genitourinary well-being is now evident. The characterization of the gut, urinary and vaginal microbiota in patients with neurogenic bladder secondary to spina bifida and multiple sclerosis can help identify a "health promoting" profile to personalize and characterize the therapeutic approach.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Analysis of Urinary, Vaginal and Intestinal Microbiota in Patients With Neurogenic Bladder
    Anticipated Study Start Date :
    Nov 10, 2023
    Anticipated Primary Completion Date :
    May 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    patients with neurogenic bladder

    Female patients of childbearing age with neurogenic bladder secondary to spina bifida and multiple sclerosis

    healthy patients

    Female patients of childbearing age without neurogenic bladder secondary to spina bifida and multiple sclerosis

    Outcome Measures

    Primary Outcome Measures

    1. Characterization of the urinary vaginal and intestinal microbiome [one day]

      Characterization of the urinary vaginal and intestinal microbiome in female patients of reproductive age with neurogenic bladder secondary to spina bifida and multiple sclerosis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    For both populations:
    • childbearing age

    • no antibiotic therapies in the last 30 days

    • no urinary tract infections/diseases in the last 30 days

    • no surgical interventions in the last 90 days

    • no intake of prebiotics or probiotics in the last 60 days

    • no estrogen-progestin or steroid hormone therapy in the last 60 days

    • no sexual intercourse in the last 3 days

    • no local vaginal therapy in the last 60 days

    • signing of the informed consent;

    • patients without lower urinary tract disorders (only for the control group);

    • patients with neurogenic bladder secondary to spina bifida (only for the study group).

    Exclusion Criteria:
    For both populations:
    • kidney or urinary tract stones

    • presence of pre-existing or ongoing intestinal pathologies (Inflammatory Bowel Diseases, chronic hepatitis, celiac disease, neoplasms, previous extensive intestinal resections)

    • ongoing diarrhea of any origin (defined as more than 6 evacuations of watery stools per day and/or faecal volume in 24 hours greater than 250 ml)

    • ongoing septic status

    • state of pregnancy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT06093035
    Other Study ID Numbers:
    • 5931
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 23, 2023