Faecal Sample Collection Resubmission
Research type
Research Study
Full title
Faecal Sample Collection from Human Healthy Volunteers for the Isolation of Microorganisms
IRAS ID
221881
Contact name
Firas Almazedi
Contact email
Sponsor organisation
Vedanta Biosciences, Inc.
Duration of Study in the UK
0 years, 1 months, 7 days
Research summary
The purpose of this study is to collect pathogen-free faecal samples for microorganism isolation by the Sponsor. Samples will be sent to the USA, and temporarily stored by the Sponsor whilst they identify, isolate, and characterize the microorganisms present in the samples. The intent is to use this information to potentially discover and commercialize new therapies, including but not limited to: small molecules, microorganisms and combinations of microorganisms, and probiotics (food additives); this is important as alterations in the microbiome are recognised as a contributing factor in autoimmune, metabolic, and infectious diseases.
The subject population will consist of healthy male and female subjects aged 18 to 60 years inclusive, with a body mass index of 18 to 30 kg/m2 inclusive, who can understand and are willing to sign an informed consent form.
The study site is the Covance Leeds Clinical Research Unit, samples will be collected on-site.
Each subject will be required to provide an acceptable stool sample (falls within the 3-5 spectra of the Bristol Stool Scale and at least 150g). If the first sample is not acceptable then the subject will be asked to provide a second sample within 14 days of signing the informed consent form. The stool sample is evaluated for pathogens and those that pass the pathogen evaluation are transferred to the Sponsor.
REC name
Wales REC 5
REC reference
17/WA/0020
Date of REC Opinion
14 Feb 2017
REC opinion
Further Information Favourable Opinion