Recruitment- Healthy volunteers

  • Research type

    Research Study

  • Full title

    Recruitment of healthy donors for the isolation of beneficial bacteria

  • IRAS ID

    220326

  • Contact name

    Nicole Reichardt

  • Contact email

    Nicole.Reichardt@4dpharmaplc.com

  • Sponsor organisation

    4D Pharma Research, Aberdeen

  • Duration of Study in the UK

    4 years, 11 months, 28 days

  • Research summary

    The human body is host to more than 100 trillion microbes that reside in a symbiotic relationship which play an important role in human health. Most bacteria present naturally in the body are harmless, and actually provide beneficial effects to the human host.
    The largest collection of the microbial population is colonised in the human gastrointestinal tract (called the gut microbiota). The advantage of simple, easy and non-invasive route of sample collection is the reason why faecal samples are used to study the (mostly anaerobic) colonic bacteria.
    The oral cavity is the foremost gateway of bacteria to enter the human body. The oral microbiota is ingested, where they propagate according to the environmental and nutrient challenges in the gut, giving rise to the colon microbiota as studied from faecal matter. Influences between buccal and faecal bacterial community profiles, make saliva a convenient, non-invasive sample for isolation of potential aerobic gut bacteria causing almost no discomfort to the donor.
    Our study aims to isolate bacteria from saliva and fresh faeces of healthy donors using anaerobic and aerobic culture methods. Screening and quality checks of isolates will be performed, which allows to streamline our search for potential biotherapeutic strains.
    At no point throughout and after the study, will any residual human cells present in the faecal sample be used or treated.
    The participants are required to be healthy, and provide us basic information about themselves. This information will be used to gauge any source of bias in our study. All data collected will be anonymised.
    The donors would need to provide a saliva sample and a fresh faecal sample (up-to 3 hours after deposition). This may be done in their homes and delivered to us, or may be done in our facilities.

  • REC name

    West Midlands - South Birmingham Research Ethics Committee

  • REC reference

    17/WM/0073

  • Date of REC Opinion

    14 Mar 2017

  • REC opinion

    Further Information Favourable Opinion