NCT04305808

Active Not Recruiting

Characterization of Vaginal, Urinary and Fecal Microbiomes i...

Hadassah Medical Organization Source

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Other study identifiers

Sponsor study identifier

0014-20-HMO

Study Type

observational

Actual enrollment (reported)

57

Locations

1 country

Sites

1

Timeline

Study Start

August 1, 2021

Actual (reported)

Primary Completion

December 30, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 30, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief Summary

The objectives are to evaluate whether variations in vaginal and/or urinary and/or fecal microbiome predispose postmenopausal women to recurrent cystitis. This will be explored using comparison of microbiome profiles between those with recurrent UTI compared to age-matched women without recurrent UTI.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: active not recruiting
Actual enrollment (reported): 57 participants
Study completion date: December 30, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 10, 2020
Actual (reported)
First Posted
March 12, 2020
Actual (reported)
Study Start
August 1, 2021
Actual (reported)
Primary Completion
December 30, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: October 29, 2026
Status Verified: October 2026
Last Update Submitted: October 27, 2026

Conditions

Urinary Tract Infections Menopause

Outcome Measures

Primary Outcomes (1)

Characterization of the microbiome using molecular methods.
Comparison of microbiome profiles between those with rUTI compared to healthy controls.
1 year

Study Arms (2)

Recurrent Urinary tract infection

Menopausal women, with two or more documented, culture-positive infections in the last six months or ≥3 infections in the last year

Healthy controls

Menopausal women, without prior history of UTIs or other urologic abnormalities.

Eligibility Criteria

Sexfemale(Gender-based eligibility)

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Menopausal women, with recurrent UTI and age-matched menopausal women without recurrent UTI.

You may qualify if:

Menopausal status

Sponsors & Collaborators

Hadassah Medical Organization
Otherlead

Study Sites (1)

Hadassah Medical Center

Jerusalem, 9765422, Israel

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vaginal, urine and fecal samples for microbiome molecular analysis.

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

Ahinoam Lev-Sagie, MD
Hadassah Medical Organization
PRINCIPAL INVESTIGATOR

Enrollment

57 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 12, 2020

Study Start

August 1, 2021

Actual (reported)

NCT05397782

Effects of Flourish on Recurrent Urinary Tract Infection

Not ApplicableCompleted

NCT04815369

Evaluating UTI Diagnosis in Nursing Homes

Withdrawn

NCT05458700

POS-cUTI: Study on Complicated Urinary Tract Infections

Recruiting

NCT05219877

Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI

Phase 1/2Completed

NCT00068120

ORWH:SCOR - Sex/Gender Factors Affecting Women's Health

Completed

NCT03819712

Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections

Not ApplicableActive Not Recruiting

Two or more documented, culture-positive infections in the last six months or ≥3 infections in the last year

You may not qualify if:

Neurogenic bladder condition
Known immunodeficiencies
Usage of antibiotics or probiotics within the previous month
Known renal calculi or anatomic malformations
Menopausal status
Sterile urine cultures, normal urinalysis, and negative sexually-transmitted PCR urine assay
\- A prior history of UTIs or other urologic abnormalities.

Contact the study team to confirm eligibility.

Primary Completion

December 30, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 30, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

October 29, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04305808
Data provider: ClinicalTrials.gov
Source updated: 2026-10-29
Normalization version: ctgov-2

Open registry record

Source retrieved: 2026-10-30 11:03:14 UTC

Locations

IL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Recurrent Urinary tract infection

Healthy controls

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations