Open-IBD

The Open-IBD project aims to improve the diagnosis and care of patients with inflammatory bowel disease (IBD) by identifying new and personalised ways to predict, monitor, and treat the condition. The initiative is an innovative partnership of patients with Crohn's disease and ulcerative colitis, genomics and immunology experts, and gastroenterologists from across the UK.

Aims of Open-IBD

The Open-IBD study aims to improve care for, and increase the quality of life of, people living with inflammatory bowel disease (IBD). The study’s research collaborator are analysing genomic and clinical data to understand how IBD develops and the biological and genetic factors that determine the speed of disease develop.

The study’s researchers seek to discover the biological molecules (biomarkers) present in patients’ biopsy, blood, and stool samples that can accurately reveal the presence and severity of diseases such as ulcerative colitis and Crohn’s disease.

The team hope that these biomarkers can then be used to:

• develop new diagnostic tests
• provide more accurate and insightful clinical monitoring
• inform and guide clinical treatment decisions
• develop new treatments.

The data gathered by the project could also yield insights into the root causes and drivers of IBD. This knowledge could reveal the underlying mechanisms that determine the speed and severity of the condition and highlight biomarkers that could be used in determining a patient’s prognosis.

Open-IBD's rationale

Inflammatory bowel disease (IBD) is used to describe conditions that cause chronic gastrointestinal inflammation. The two main types are Crohn’s disease and ulcerative colitis.

Until now, almost all research into IBD has been undertaken in patients who have lived with their condition for many years and have tried a range of therapies. Because of this, it hasn’t been possible to discover the initial factors that trigger IBD or explore the key cellular and biological pathways involved in disease progression.

The Open-IBD project has been specifically designed to enable researchers to probe the underlying causes of, and processes driving disease progression in, IBD by focusing on patients who have just started to experience IBD. The project recruits participants at their first referral to hospital with suspected IBD and before any treatment has been given.

Recruiting patients will begin in early 2025.

Open-IBD's data collection

Open-IBD collects in-depth genomic and clinical data from 1,000 IBD patients at diagnosis and multiple points for up to four years. The result will be an invaluable data resource to understanding and exploring how IBD develops by containing:

• molecular
• cellular
• bacterial
• viral
• genetic information.

Working in partnership with patients

The Open-IBD project’s team is keen to ensure that all needs and concerns are explored and addressed so that everyone involved – patients, researchers and clinicians – benefits from the study.

For this reason, the design of the project and its implementation has been formed in close collaboration with the assistance of the patient advocacy charity Crohn’s & Colitis UK and in direct consultation with patients through focus groups.

Open-IBD's study design

On referral to hospital, patients with inflammatory bowel disease (IBD) will be invited to join the Open-IBD study. Upon agreeing to take part, patients be asked to provide blood and stool samples, and answer an in-depth clinical information questionnaire with a researcher. In addition, the study will analyse the participants’ biopsy samples that are taken when they undergo a diagnostic colonoscopy.

Over the course of the first two years after hospital referral, further samples will be taken at regular intervals. These include any biopsy samples taken during a second colonoscopy a year after diagnosis.
How the samples will be analysed:

• The biopsy and blood samples will be analysed using single-cell RNA sequencing.
• Stool samples will undergo metagenomics shotgun sequencing and RNA gene sequencing.
• DNA samples from all individuals will be sequenced to identify genetic factors underpinning disease progression and prognosis.

In addition, clinical information about the course of the disease and treatment outcomes will continue to be collected up to four years after initial consent.

Academic Partners

Open-IBD brings together experts from academic institutions across the UK and is led by co-Chief Investigators, Dr Chis Lamb from Newcastle University and Dr Carl Anderson from the Wellcome Sanger Institute.

Hospital partners

Patients are recruited expert clinician scientists from specialist IBD clinics at seven hospitals:

• Newcastle upon Tyne Hospitals
• Cambridge University Hospitals
• NHS Lothian
• Royal Devon University Healthcare
• Barts Health NHS Trust
• Guy’s & St Thomas’ Hospital
• St George’s University Hospitals

Pharmaceutical research partners

The Open Targets consortium’s pharmaceutical partners will work closely with the study’s researchers to ensure the study’s findings can be translated into patient benefit as quickly as possible.

Building IBD research capacity

To enable further research into IBD by scientists around the world, the study’s data – anonymised to protect participants’ privacy – will be made open and accessible to the global research community once published.

In addition, the Open-IBD study funds a research nurse and a clinical PhD fellow at each of the seven hospitals taking part to support patient recruitment and analysis. The clinical fellows are trained in using genomics, big data and statistics, and are mentored by current experts to become the next generation of leaders in gastroenterology.

Funding

The project is funded by Open Targets (an innovative pre-competitive public-private research partnership) and the Wellcome Sanger Institute.