The NIHR is the nation's largest funder of health and care research and provides the people, facilities and technology that enable research to thrive. We work in partnership with the NHS, universities, local government, other research funders (including industry and charities), patients and the public to improve the health and wealth of the nation.
In 2017/18, the NIHR spent £13.7 on research studies into gastrointestinal conditions. The NIHR Clinical Research Network (CRN) supported 232 gastroenterology studies, 71 of which were new studies and recruited 28,840 patients to studies last year (2019/20).
CONSTRUCT IFX NHS Impact Case Study
Ulcerative colitis (UC) is a chronic debilitating disease that affects about 150,000 people in the UK, where the colon and rectum become inflamed, causing diarrhoea and abdominal pain. It often leads to frequent and long in-patients stays and emergency colectomy (surgery to remove the colon), and is therefore a major burden on patients and NHS resources. Recent studies have reported that two drugs, infliximab and cyclosporin, are often effective at treating steroid-resistant ulcerative colitis in the short term, but there was a lack of studies comparing the two treatments. The aim of this study was to compare the clinical and cost effectiveness of infliximab and ciclosporin in acute severe steroid-resistant ulcerative colitis.
The CONSTRUCT trial aimed to test their relative clinical effectiveness, measured by quality of life and cost-effectiveness. The study, led by Prof John Williams from Swansea and funded by the NIHR Health Technology Assessment (HTA) Programme, recruited 270 patients from 52 hospitals across England, Scotland and Wales. The gastroenterology community worked hard to deliver this largest study ever done in acutely ill hospitalised UC patients. It found that Cyclosporin and infliximab were both equally effective in treating acute severe colitis.
In Barrett’s oesophagus, the cells that line the oesophagus become damaged by acid reflux, which can cause symptoms such as indigestion and heartburn. Over a long period of time, people with Barrett's oesophagus can develop ulcers or a narrowing of the oesophagus, and in some cases oesophageal cancer.
The ‘Cytosponge’ is a ‘pill on a string’ that is being tested to detect oesophageal cancer in people with Barrett’s oesophagus. The Cytosponge sits within a pill which, when swallowed, dissolves to reveal a sponge that scrapes off cells when withdrawn up the gullet. It allows doctors to collect cells from all along the gullet, whereas standard biopsies take individual point samples, to diagnose.
The device was initially tested at the NIHR Cambridge Clinical Research Facility. Further research, funded by Cancer Research UK, is supported by the NIHR Clinical Research Network. The latest trial, which aims to recruit nearly 9000 patients, is the last step required before the Cytosponge could be adopted into mainstream practice.
TOPPIC-the largest study of thiopurines in post-operative Crohn’s disease
Crohn’s disease is a serious disease in which there is swelling and ulceration of the gut wall. Most patients are treated with medicines. But after ten years, 2 out 3 people with Crohn’s disease will need an operation. Crohn’s disease can often come back after an operation, and almost half those who had an operation will need another one.
Several medicines have been tested to see if they help stop Crohn’s disease coming back after an operation. The 5ASA medicines are not very good at stopping Crohn’s coming back. Antibiotics have some effect but cannot be taken for very long because of side effects. Azathioprine and 6-Mercaptopurine (together known as thiopurines) are medicines that alter the way the immune system works. Over the last 10 years, they have become widely used for Crohn’s disease when it is not easily treated with other medicines but is not serious enough to need an operation. They have also been tested to see if they can stop Crohn’s disease coming back after an operation, but those studies have been flawed and the results have been unhelpful for doctors.
Led by Prof Jack Satsangi and funded by the Medical Research Council, the TOPPIC study recruited 240 patients from 29 UK hospitals between 2008 and 2012. The study randomly allocated patients to receive 6-Mercaptopurine or placebo. It found that smokers had a high rate of recurrence of Crohn’s disease and 6-Mercaptopurine was effective in preventing recurrence mainly in smokers.
Bowel cancer is common in the UK. Most bowel cancers happen when a type of polyp (a growth in the bowel) called an adenoma becomes cancerous. Doctors use a camera test, known as a colonoscopy, to look inside the bowel, find these polyps and remove them. Removing pre-cancerous polyps is known to reduce the chances of a person developing bowel cancer in the future. How good colonoscopists are at finding these polyps varies, and there is a lot of research into how to improve “adenoma detection rates”.
A new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which holds the folds of the bowel back to give a clear view of the inside of the bowel) has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous small studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%).
The ADENOMA study (led by Prof Colin Rees) randomly allocated patients coming for colonoscopy to have their procedure performed as usual (i.e. without the Endocuff Vision attached) or as an Endocuff-assisted colonoscopy. The study aimed to recruit 1772 patients across England in 7 centres (1 in London and the remainder in North East England) and did this successfully ahead of time.
You can find out more about gastroenterology studies in your area through Be Part of Research website.
The NIHR Clinical Research Network (CRN) provides researchers with the practical support they need to make clinical studies happen in the NHS. We provide world-class health service infrastructure - research support staff such as clinical research nurses, and research support services such as pharmacy, pathology and radiology - to support organisations seeking to conduct clinical research in the NHS in England. Some of this research is funded by the NIHR, but most of it is funded by NHS non-commercial partners and industry.
The Gastroenterology Specialty is one of 30 specialties which bring together communities of clinical practice to provide national networks of research expertise and clinical leadership. It is made up of research-interested clinicians and practitioners who work at both national and local levels to ensure the studies that are included in our national portfolio of research are delivered successfully in the NHS- to time and target.
The Gastroenterology Specialty supports a national portfolio of high quality research studies relating to the pathogenesis, diagnosis, treatment and prevention of gastrointestinal disorders. We support researchers to deliver high quality studies to time and target in the NHS. We do this by engaging with the existing research community and developing local research infrastructure.
Gastroenterology Clinical Specialty leads
The Clinical Research Network is made up of 15 localities covering England. Each one has a nominated local lead for gastroenterology research who promotes and supports gastroenterology research within the NHS Trusts in their area. At a national level the local leads come together to manage the national gastroenterology research portfolio overall. This involves regularly reviewing the progress of studies, identifying barriers to recruitment, and coming up with solutions and strategies to help overcome those barriers. The national Specialty Groups also engage with funders of research and other stakeholders to help ensure that there is a continuous pipeline of high quality research studies and the capacity to deliver these successfully in the NHS.
Key achievements of the CRN Gastroenterology Specialty include:
Expanding portfolio of intervention studies, particularly Inflammatory Bowel Disease trials
Opportunity for NHS patients to access treatment advances through trials
Excellent national coverage giving the widest participation opportunities for patients
Large networks for biobanking and data registries
Patient-Public Research Priority Setting Partnerships
The Gastroenterology Specialty portfolio covers research pertaining to the whole gastrointestinal tract and includes:
Inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis
A new initiative aimed at encouraging more inflammatory bowel disease (IBD) Clinical Nurse Specialists to get involved in clinical research as part of their role has launched.
In response to the results from questions asked in a survey led by the Royal College of Nursing to IBD Clinical Nurse Specialists. One of the survey questions asked whether they were interested in developing their role in relation to clinical research. Two thirds said they were interested in getting more involved in research.
Clinical Research Network Gastroenterology National Specialty Lead Professor Mark Hull who led the initiative said:
“It’s fantastic to see such a positive response to the initiative promoting clinical nurse specialists to get more involved in clinical research. Two thirds of studies being delivered through the Gastroenterology specialty portfolio are related to IBD, and there’s a real need to ensure that as many patients as possible have the opportunity to take part in research that’s available to them.
“Clinical nurse specialists are the ‘eyes and ears’ of hospital IBD teams and have close contact with their patients through all stages of their treatment, so it’s a really positive step forward that many could also support their patients through a research journey.”
The key output is to:
define ways that Clinical Nurse Specialists can support or lead NIHR Portfolio studies or do their own research.
Find out more about this initiative in these videos.
Professor Mark Hull National Specialty Lead
Professor Hull, explores why there is a need to encourage more inflammatory bowel disease (IBD) Clinical Nurse Specialists to get involved in clinical research as part of their role.
Dr Karen Kemp Consultant Nurse IBD
Dr Kemp, describes some of the models that can be used to integrate clinical research into the inflammatory bowel disease (IBD) Clinical Nurse Specialists role.
Janette Dunkerley Lead Nurse
Janette describes the importance and benefits of Clinical Nurse Specialists being involved in clinical research.
Some of our key stakeholders are listed below. The NIHR Clinical Research Network Gastroenterology specialty group works closely with these organisations in integrating clinical research into NHS clinical service provision, and in driving priority setting that encourages research that will have the greatest impact on patients.
The CRN Gastroenterology National Specialty Group membership includes representation from the British Society of Gastroenterology (BSG), who we work closely with.
British Society of Gastroenterology
The British Society of Gastroenterology (BSG) is an organisation focused on the promotion of gastroenterology within the United Kingdom. It has over three thousand members drawn from the ranks of physicians, surgeons, pathologists, radiologists, scientists, nurses, dieticians, and others interested in the field.
Crohn’s and Colitis UK is the working name for the National Association for Colitis and Crohn’s Disease (NACC). Founded in 1979, the charity has been providing information and support, funding research and fighting for change by bringing together people of all ages who have been diagnosed with IBD, their families and friends, and the professionals involved in their care.
The charity for the digestive system. This charity was set up to change something – to increase the levels of research into diseases of the gut, liver and pancreas so no one suffers in silence or alone. Since 1971 we have funded almost 300 projects and invested £15 million pounds into medical research that leads to better diagnoses and treatments for the millions of people who, like us, don’t have the luxury of taking our guts for granted. Guts UK’s vision is of a world where digestive disorders are better understood, better treated and everyone who lives with one gets the support they need. Our mission as Guts UK is to provide expert information, raise public awareness of digestive health and transform the landscape for research into our digestive system to help people affected by diseases of the gut, liver and pancreas.
Coeliac UK represent over 60,000 Members who have coeliac disease and/or dermatitis herpetiformis. We’re here to work on behalf of those with the condition and create change to make things better whilst providing support for everyday living and furthering our understanding through research.
Bowel disease has historically been the most neglected of common diseases. As a result research has been grossly under-funded, especially considering the very great potential for significant advance. BDRF funds practically-oriented research which increases understanding while delivering direct and demonstrable improvements in the treatment of and survival rates for people with bowel disease.
British Association of Parental and Enteral Nutrition (BAPEN)
BAPEN is a Charitable Association that raises awareness of malnutrition and works to advance the nutritional care of patients and those at risk from malnutrition in the wider community. BAPEN raises awareness and understanding of malnutrition in all settings and provides education, advice and resources to advance the nutritional care of patients and those at risk from malnutrition in the wider community.
The NIHR provides the support and facilities the NHS needs for first-class research by funding a range of infrastructure.
NIHR Biomedical Research Centres
NIHR Biomedical Research Centres (BRCs), partnerships between England’s leading NHS organisations and universities, conduct translational research to transform scientific breakthroughs into life-saving treatments for patients with gastrointestinal conditions. The following BRCs undertake gastroenterology research:
NIHR Health Protection Research Units (HPRUs) are research partnerships between universities and Public Health England and act as centres of excellence in multidisciplinary health protection research in England. The following HPRU undertakes research in gastroenterology:
The NIHR IBD Bioresource is a national platform designed to expedite research into Crohn’s disease and ulcerative colitis and help develop new and better therapies.
Work with our infrastructure
All of the NIHR facilities and centres are opening to working with the public, charities, industry and other partners. If you are interested in collaborating with the NIHR please contact the NIHR Office for Clinical Research infrastructure: email@example.com
Our experts in the NIHR Clinical Research Network National Specialty Group can advise on delivering your gastroenterology study in the NHS.
National Specialty Lead
Professor Mark Hull
Mark Hull is Professor of Molecular Gastroenterology, and Honorary Consultant Gastroenterologist at the University of Leeds. He has a general gastroenterology practice including management of inflammatory bowel disease.
Mark trained in Cambridge and Oxford and then obtained the PhD degree from the University of Nottingham studying gastric ulceration. He has held a number of prestigious research awards in the field of cancer chemoprevention including a MRC Clinician Scientist Award and MRC Senior Fellowship.
He has been Chair of the British Society of Gastroenterology Research Committee responsible for the Society’s Research Strategy.
As an expert on colorectal cancer prevention, he runs a laboratory programme and leads clinical trials on chemoprevention agents. He was Chair of the NCRI Clinical Studies Group on CRC screening & prevention and sits on multiple Trial and NIHR Committees.