MOBIDIC Patient Study
Research type
Research Study
Full title
Molecular Biomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection study in Crohn's disease patients (MOBIDIC)
IRAS ID
203047
Contact name
Jean-Michel Paillarse
Contact email
Sponsor organisation
Enterome Bioscience
Duration of Study in the UK
0 years, 9 months, 2 days
Research summary
This a multicentre, international study to be conducted in France, UK, Ireland and USA. Up to 350 patients will be enrolled over all sites. The purpose of the study is to develop a method of detection of Adherent and Invasive Escherichia Coli (AIEC), thought to be the main cause of Crohn’s Disease (CD), and to determine genetic susceptibility (if the patient is a carrier) to CD.
Patients with CD who are on the NHS database and are scheduled to attend the clinic for routine colonoscopy will be informed of the study and invited to participate.
The study consists of two visits approximately 10 to 90 days apart to allow for collection of a stool sample between 7 and 15 days prior to attending for the colonoscopy procedure. During the colonoscopy procedure biopsies will be taken.Visit 1 will involve informed consent, medical examination, HBI assessment (index of CD activity), provision of a stool collection kit, and CD Activity Index/diary.
Visit 2 will involve blood sampling for obtaining a blood count, detection of CD antibodies and DNA for genotyping. In addition an pre-arranged ileocolonoscopy (examination of the colon and ileum), will be performed and recorded by video and four biopsies of the ileum will be taken during the procedure.
The stool samples and biopsies will be analysed (DNA analysis will be performed) to determine if there is any predisposition to the specific bacteria being studied in the gut in order to develop a predictive algorithm (method of predicting likelihood).
Biomarkers from all analysis that can be identified will form the development of the algorithm to label patients as carriers or non-carriers.
There are no study overnight stays required, patients will attend on an outpatient basis.
The maximum duration of the study for each patient will be 12 weeks.
REC name
HSC REC B
REC reference
16/NI/0116
Date of REC Opinion
14 Jun 2016
REC opinion
Favourable Opinion