Open-IBD v1.0
Research type
Research Study
Full title
Open-IBD: A longitudinal multi-omics inception cohort in inflammatory bowel disease
IRAS ID
345768
Contact name
Chris Lamb
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
Inflammatory bowel disease (IBD) is a long-term, debilitating condition that causes inflammation of the digestive tract. Approximately 1 in 123 people in the UK are living with IBD, and this is continuing to rise.
Symptoms and disease behaviour varies significantly from person to person. The exact cause of IBD, and what influences this variation remains unknown. By studying human blood and gut cells, and gut microbes (bacteria, viruses and fungi) early in the disease course the Open-IBD team aim to better understand this biological variability. Additionally, the aim is to develop strategies to identify which people most need treatment early after diagnosis, and which treatment to choose.
Patients over the age of 16 years old, referred to hospital with a suspected diagnosis of IBD will be recruited prior to their diagnostic colonoscopy. Patients will be asked to complete questionnaires regarding their health and lifestyle and provide blood and stool samples. Additional biopsies will be taken for research purposes during their colonoscopy. Patients diagnosed with IBD will be reviewed 6 times over the subsequent 2 years. During these visits they will complete questionnaires and provide further blood and stool samples. They will have a repeat colonoscopy 12 months after diagnosis. Relevant information from medical notes will be recorded 3 and 4 years after diagnosis. The medical notes of patients not diagnosed with IBD will be reviewed remotely at 3 months then annually for up to 4 years to assess for the interval development of IBD. The visits will be conducted at the same sites that patients receive their clinical care.
Samples taken will be analysed for human and microbe cells, genetic material and metabolic products that may determine an individual patient’s pattern of disease and guide the most effective treatment options.
REC name
Wales REC 1
REC reference
24/WA/0338
Date of REC Opinion
16 Dec 2024
REC opinion
Further Information Favourable Opinion