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Assessing whether testing of rectal swabs is as accurate as bulk faeces testing in diagnosis of bacterial infections.

Rectal Swabs vs Bulk Faeces PCR testing for the Diagnosis of Enteric Conditions (RecSwabFaeces)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000095561
Enrollment
300
Registered
2024-02-02
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-02-12

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

Conditions

None listed

Brief summary

We are verifying if rectal swabs are as accurate as builk faeces testing in routine clinical care. We hypothesise that these two tests are equally as accurate and it would mean that it is easier to obtain medical tests for gastrointestinal organisms during routine clinical care.

Interventions

We will compare paired stool and rectal swab sample PCR testing to investigate whether rectal swabs are a reliable proxy for faecal sampling. Tests would be done in accordance with normal clinical practice. Persons who would normally be provided with a faecal specimen jar, will also be provided with a rectal swab to perform themselves (within 24 hours of the faeces collection, preferably as the first step). Written instructions with diagrams will be provided to the participant prior to testing.

We will compare paired stool and rectal swab sample PCR testing to investigate whether rectal swabs are a reliable proxy for faecal sampling. Tests would be done in accordance with normal clinical practice. Persons who would normally be provided with a faecal specimen jar, will also be provided with a rectal swab to perform themselves (within 24 hours of the faeces collection, preferably as the first step). Written instructions with diagrams will be provided to the participant prior to testing. The person will obtain 1x faecal sample and 1x rectal swab sample. Rectal swab collection was carried out at the same time as stool sample production and was obtained by self-insertion via the anus to a depth of 2–3 cm and rotated 3-5 times and ensure it is soiled. Faecal samples and rectal swabs will be returned to a local hospital to be sent to Pathology Queensland. These will be sent to FSS for paired sample testing of Hepatitis A PCR if they are part of a Hepatitis A cluster. The samples will be sent to Pathology Queensland for multiplex PCR assays for a range of organisms (including norovirus) if the setting is in community settings or hospital and not part of an outbreak.

Sponsors

Sunshine Coast Hospital and Health Service
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Persons aged 18 and older Able to consent to and perform the additional rectal swab test. Close contact or person exposed, suspected or confirmed case associated with an outbreak of an enteric organism. E.g. hepatitis A outbreak, foodbourne outbreak. Chronic carrier of an enteric organism that requires testing. Person involved in a clinical encounter where they are, or likely suffering from a disease caused by an enteric organism. (E.g. person presenting to the GP or Emergency Department with diarrhoea or jaundice)

Exclusion criteria

Persons unlikely (as judged by the clinician) to be harbouring an enteric organism.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026