Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000420448
Ethics application status
Approved
Date submitted
23/04/2025
Date registered
8/05/2025
Date last updated
8/05/2025
Date data sharing statement initially provided
8/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of secretor status in shaping gut and genitourinary bacteria, and its link to genitourinary infections
Scientific title
Investigating the influence of secretor status on the genitourinary and gut microbiome, and its association with genitourinary infections in women of reproductive age
Secondary ID [1] 314239 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Genitourinary infection 337156 0
Gut microbiome 337307 0
Genitourinary microbiome 337312 0
Condition category
Condition code
Renal and Urogenital 333573 333573 0 0
Normal development and function of male and female renal and urogenital system
Oral and Gastrointestinal 333574 333574 0 0
Normal oral and gastrointestinal development and function
Infection 333575 333575 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Secretor status, which is determined by the FUT2 genetic marker, affects an individual’s ability to secrete ABO antigens in bodily fluids and in tissues other than red blood cells. Non-secretor lacks ABO antigens in their bodily fluids and tissues. These antigens can serve as energy sources and adhesion receptors for bacteria, thereby potentially influencing an individual’s susceptibility to certain bacterial colonisation and infections.

This is an observational study recruiting females (aged between 18 to 45 years) who are of reproductive age. Participants will attend a single visit at the start of the study (duration ~ 30 minutes), to self-collect saliva/cheek swab, urine sample, vaginal swab and stool sample (collected on-site or at home). Participants will complete questionnaires at baseline including on general health conditions, genitourinary symptoms and/or infection, supplements/medication, menstruation cycle and lifestyle. The baseline questionnaire also collected participants' self-reported information on history of genitourinary infections over the past three years. Similar follow-up questionnaires will be completed at 6-months and 1-year. Each questionnaire requires approximately 10 - 20 minutes to complete. Participants who experience a urinary tract infection during the 1-year follow up period may provide urine and stool samples by either scheduling a supplementary visit or arranging for sample pick-up by the study team at a designated location. Samples will not be collected during menstruation. FUT2 secretor status will be determined from saliva/cheek swab and will be used to compare non-secretors with the secretor group.
Intervention code [1] 330854 0
Not applicable
Comparator / control treatment
Participants identified as secretors (being either homozygous or heterozygous for the wild-type FUT2 gene) will be assigned as the control group for analyses.
Control group
Active

Outcomes
Primary outcome [1] 341153 0
Incidences of genitourinary infection
Timepoint [1] 341153 0
Retrospective data collected from questionnaires at baseline for incidences of genitourinary infection in the past 3 years. Prospective data on incidences collected from questionnaires at 6 months and 12 months post-enrollment..
Primary outcome [2] 341154 0
Genitourinary microbiome profile
Timepoint [2] 341154 0
Baseline.
Primary outcome [3] 341292 0
Gut microbiome profile
Timepoint [3] 341292 0
Baseline.
Secondary outcome [1] 446516 0
Types of medication taken
Timepoint [1] 446516 0
Baseline, 6 months and 12 months post-enrollment
Secondary outcome [2] 447029 0
Urinary tract infection symptoms
Timepoint [2] 447029 0
Baseline, 6 months and 12 months post-enrollment
Secondary outcome [3] 447037 0
Contraceptive practices
Timepoint [3] 447037 0
Baseline, 6 months and 12 months post-enrollment

Eligibility
Key inclusion criteria
• Pre-menopausal female
• BMI 18.5 to 35
• no recurrent UTI
• not currently pregnant or breastfeeding or planning to be pregnant within the next 12 months
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• urinary tract infection within 30 days
• use of antibiotics within 3 months
• use of medication within 30 days (including antifungals, vaginal medication, oral steroids, immunosuppressives)
• sexually transmitted disease within 30 days
• diarrhoea within 30 days
• enrolled in an interventional trial study within 30 days
• chemotherapy, hospitalisation or urinary catheterization within 3 months
• conditions including diabetes mellitus; clinical kidney, liver or immunological diseases; inflammatory bowel disease; neurological disease; functional or structural problems of the vagina or urinary tract (including hysterectomy, current or intermittent use of indwelling catheter)

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Primary outcomes will be assessed using multivariate analyses to determine group differences (between secretors and non-secretors) in genitourinary infection rates, as well as urinary, vaginal and stool microbiota profiles. Secondary outcomes will be explored by examining associations between the vaginal microbiota and genitourinary infections, as well as lifestyle and behavioural variables.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
7/03/2023
Date of last participant enrolment
Anticipated
Actual
1/04/2025
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
300
Accrual to date
Final
241
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318756 0
University
Name [1] 318756 0
Flinders University
Country [1] 318756 0
Australia
Funding source category [2] 318765 0
Other
Name [2] 318765 0
South Australian Health and Medical Research Institute
Country [2] 318765 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 321198 0
Other
Name [1] 321198 0
South Australian Health and Medical Research Institute
Address [1] 321198 0
Country [1] 321198 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317370 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 317370 0
Ethics committee country [1] 317370 0
Australia
Date submitted for ethics approval [1] 317370 0
26/08/2022
Approval date [1] 317370 0
07/09/2022
Ethics approval number [1] 317370 0
2022/HRE00145

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140838 0
Dr Jocelyn Choo
Address 140838 0
SAHMRI, 2 North Terrace, Adelaide SA 5000
Country 140838 0
Australia
Phone 140838 0
+61881284063
Fax 140838 0
Email 140838 0
[email protected]
Contact person for public queries
Name 140839 0
Jocelyn Choo
Address 140839 0
SAHMRI, 2 North Terrace, Adelaide SA 5000
Country 140839 0
Australia
Phone 140839 0
+61881284063
Fax 140839 0
Email 140839 0
[email protected]
Contact person for scientific queries
Name 140840 0
Jocelyn Choo
Address 140840 0
SAHMRI, 2 North Terrace, Adelaide SA 5000
Country 140840 0
Australia
Phone 140840 0
+61881284063
Fax 140840 0
Email 140840 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.