Characterisation of dysbiosis and immune responses in IBD.
Research type
Research Study
Full title
Characterisation of dysbiosis and concurrent changes in the immune responses in inflammatory disease patients under biological treatment.
IRAS ID
194785
Contact name
Hafid Omar
Contact email
Sponsor organisation
University of Wolverhampton
Clinicaltrials.gov Identifier
FSE4, QR/FSE Funding Panels Outcomes
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The gastrointestinal tract is in contact with a huge variety of beneficial and harmful bacteria. Therefore, a balance between immunity to fight harmful bacteria and immune tolerance to beneficial bacteria is required. Disruption in this balance can cause inflammatory bowel disease such as Crohn’s disease; a chronic relapsing incurable inflammatory bowel disease affecting 165/100000 people in the UK. The cytokine milieu (hormones) in the intestine is an important factor in the maintenance of this balance. For example, in Crohn’s disease we found that the levels of cytokines associated with inflammation are elevated whereas levels of cytokines associated with normal tissue were reduced. Probiotic treatment; (a mixture of beneficial bacteria), has been effective in prevention of inflammation and maintenance of remission but probiotics are ineffective in treating an established inflammation. However, using biotherapeutics such as monoclonal antibodies have been effective in the treatment of inflammation. Infliximab is one of these biotherapeutic agents but some patients do not respond to this treatment, some develop serious side effects and/or recurrence after the treatment is discontinued. This may be due to changes in the bacterial population (Dysbiosis) in the gut. Dysbiosis plays a major role in the progression of Crohn’s disease leading to elevated levels of inflammatory cytokine in the circulation.\nWe aim to characterise the persistent dysbiosis in Crohn’s disease patients and examine concurrent changes in serum cytokine profiles before and after treatment. Results will further our understanding of bacterial composition/diversity in the human gut and may lead to optimisation of probiotic preparations for inflammatory bowel disease treatment.\nBlood and stool samples will be obtained from patients diagnosed with Crohn’s disease, 6-8 weeks before treatment and nine months post treatment at New Cross Hospital. Samples will be analysed in the laboratories of Wolverhampton University.\n\n
REC name
North of Scotland Research Ethics Committee 2
REC reference
16/NS/0126
Date of REC Opinion
9 Dec 2016
REC opinion
Further Information Favourable Opinion