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The influence of secretor status in shaping gut and genitourinary bacteria, and its link to genitourinary infections

Investigating the influence of secretor status on the genitourinary and gut microbiome, and its association with genitourinary infections in women of reproductive age

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625000420448
Enrollment
241
Registered
2025-05-08
Start date
2023-03-07
Completion date
2025-04-01
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This observational study aims to investigate the influence of FUT2 secretor status on the genitourinary and gut microbiota, as well as on the incidence of genitourinary infections. The hypotheses tested are: 1) whether genitourinary and gut microbiota differs between secretors and non-secretors, and 2) whether FUT2 secretor status or specific microbial profiles are associated with genitourinary infections. The study will also examine the effects of lifestyle and behavioural exposures on the vaginal microbiota. The study findings will improve our understanding on the biological and external factors that shape the microbial communities in the genitourinary tract and gut, as well as the bacterial interactions associated with the development of genitourinary infections.

Interventions

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

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.

Sponsors

Flinders University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026