Microbial ColonizationNCT06093035
Analysis of Urinary, Vaginal and Intestinal Microbiota in Patients With Neurogenic Bladder
An observational study of Microbial Colonization, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2023to 31 Dec 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female patients of childbearing age with/without neurogenic bladder secondary to spina bifida and multiple sclerosis.
Who may be able to join
- 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
Show all 12Show fewer
- 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).
Who cannot join
- 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
About this study
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.
- Conditions
- Microbial Colonization
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the urinary vaginal and intestinal microbiome
Characterization of the urinary vaginal and intestinal microbiome in female patients of reproductive age with neurogenic bladder secondary to spina bifida and multiple sclerosis
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start10 Nov 2023 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093035
- Sponsor's protocol ID
- 5931
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Urinary, Vaginal and Intestinal Microbiota in Patients With Neurogenic Bladder
- ClinicalTrials.gov ID
- NCT06093035
- Acronym / sponsor ID
- 5931
- Conditions
- Microbial Colonization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 10 Nov 2023 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female patients of childbearing age with/without neurogenic bladder secondary to spina bifida and multiple sclerosis.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of the urinary vaginal and intestinal microbiome
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbial Colonization, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the urinary vaginal and intestinal microbiome (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.