Introduction
Digestion is essential for all bodily functions, as all nutrients and energy are processed and absorbed in the intestinal system. Diseases of the digestive system can affect the gastrointestinal tract and related organs, such as the pancreas, liver, and bile ducts. The most common conditions include functional disorders, inflammatory diseases, infections, and cancer.
Recruitment strategies for clinical trials may vary depending on the primary point of care and whether the condition is common or rare. In many cases, good collaboration with referring doctors and other hospitals is essential.
Organization
NorTrials Gastrointestinal is located at the University Hospital of North Norway (UNN) under the Medical Division, Section for Digestive Diseases. Our premises are located at the Gastro Lab, where we have easy access to necessary equipment and procedures, such as endoscopy, ultrasound and laboratory facilities.
Patient Population
UNN Tromsø serves as a local hospital for approximately 130,000 people and as a university hospital for around 490,000 in Northern Norway. Through its university function and professional networks, we maintain close collaboration with local hospitals across Northern Norway and have strong connections with both university hospitals and local hospitals throughout the country.
Network
We have research collaborations with research environments at all university hospitals in Norway and are actively working to expand the network to include all local hospitals across the country. We collaborate with patient organisations such as the Coeliac Society and the Gastrointestinal Association for recruitment to both our own trials and commissioned trials. Internationally, we have partnerships with research groups in England, Denmark, and Sweden in connection with academic trials.
Trial Experience and Delivery
At the Research Group for Gastroenterology and Nutrition (GNU), we have spent many years researching disease mechanisms and working on tailored treatments, particularly in the areas of inflammatory bowel diseases (IBD), obesity, neuroendocrine tumours, and the stomach ulcer bacterium. We have also conducted experimental treatment trials involving faecal microbiota transplantation for various conditions.
Since the launch of NorTrials Gastrointestinal in September 2022, we have increased our activity with industry sponsored trials, where new medications are being tested for the pharmaceutical industry, recruiting participants with various diagnoses such as inflammatory bowel disease, eosinophilic oesophagitis, and coeliac disease. These trials range from phase II to phase IV.
Employees and Contact Information
Location: Gastrolab B8, UNN Tromsø
Study nurses: Hilde Rognli-Johannessen and Elisabeth Blomli
References/Publications
The research group's web page gives an overview of academic trials and publications.
Ongoing Trials
CROSSING (AstraZeneca). Recruits patients with eosinophilic oesophagitis who do not achieve full effect from standard treatment.
GALOCEAN (Galapagos). Recruits patients with ulcerative colitis who are starting treatment with the medication Jyseleca.
M23-703 (Abbvie). Recruits patients with ulcerative colitis who have moderate to severe disease.
CEC13-CEL (Dr Falk). Recruits patients with coeliac disease who continue to have symptoms despite following a gluten-free diet.
Upcoming Trials:
FIRST (Optimapharm). Recruits patients with primary biliary cholangitis who do not achieve full effect from standard treatment.