Pilot study comparing types of microbiome sample

  • Research type

    Research Study

  • Full title

    Pilot study comparing types of microbiome sample: fresh stool (pre-bowel prep), stool collected at colonoscopy(post-bowel prep), mucosal biopsy, formalin-fixed paraffin embedded material (FFPE), OriCol™ mucosal sample (collected both pre and post bowel prep).

  • IRAS ID

    188025

  • Contact name

    Philip Quirke

  • Contact email

    p.quirke@leeds.ac.uk

  • Sponsor organisation

    University of Leeds

  • Duration of Study in the UK

    3 years, 0 months, 1 days

  • Research summary

    The microbiome is the term used to describe the bacteria, viruses and fungi which live in/on the body. Most are bacteria within the bowel. Research suggests that different microbiomes are associated with various different diseases.

    At the moment, researchers study the gut microbiome by extracting bacterial DNA from either fresh stool samples (collected by the patient or at the time of colonoscopy) or biopsy of the bowel wall (performed at colonoscopy). This pilot project will compare these methods to two alternative microbiome-sampling methods:
    1)The OriCol™ sampling device.
    2) Formalin fixed paraffin embedded (FFPE) blocks.

    The OriCol™ sampling device is a CE marked device which samples the rectal mucosa. The clinician inserts a proctoscope into the rectum and inflates the OriCol™ nitrile membrane with air, bringing the device into contact with the rectal mucosa for 10 seconds. The device is then deflated and withdrawn. The advantage of this sampling method is that it can be performed quickly and easily in an outpatient/GP setting and does not require the patient to collect stool.

    FFPE "wax" blocks are the way that hospitals store tissue samples. Hospitals have large archives of FFPE samples from patients with many different diseases, some of which are very rare. If this study shows that the microbiome can be analysed from these samples, this would mean that microbiome research could be conducted without having to take further biopsies or ask patients to go to the inconvenience of collecting stool.

  • REC name

    Yorkshire & The Humber - Leeds West Research Ethics Committee

  • REC reference

    16/YH/0488

  • Date of REC Opinion

    11 May 2017

  • REC opinion

    Further Information Favourable Opinion