Better understanding of the causes, how best to treat and how to develop new medications for Crohn’s and colitis by studying human cells and gut microbes
| ISRCTN | ISRCTN15535639 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15535639 |
| IRAS number | 345768 |
| Secondary identifying numbers | CPMS 65251, Grant Codes: 220540/Z/20/A |
- Submission date
- 27/01/2025
- Registration date
- 01/04/2025
- Last edited
- 01/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
The number of new people being diagnosed with Crohn’s and colitis is rising each year. Symptoms can be very different from one person to the next - some people will have inflammation which gets worse over time whereas in others the inflammation is easily treated. Unfortunately, we don’t know why Crohn’s and colitis starts or what controls this behaviour over time. Our team of researchers think that studying the behaviour of human cells in the blood and gut, studying gut microbes (bacteria, viruses and fungi) and other factors at the time of Crohn’s and colitis diagnosis and repeatedly over the first 2 years after diagnosis may help to better understand why everyone’s experience is so different and what makes us so individual. We hope that doing this will allow us to work out which people most need treatment early after diagnosis, and which treatment to choose. We hope this study in the future will help to better predict how Crohn’s and colitis may behave for different people, make new treatments for Crohn’s and colitis and support people to make personalised choices about their care with their doctors and IBD nurses.
The study aim is to recruit 1,000 IBD participants and up to 1,000 non-IBD control participants and collect health data and biosamples for research. 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.
Who can participate?
Adults aged 16 years and over with a suspected diagnosis of IBD
What does the study involve?
This study involves collecting information and samples from people who have symptoms that mean they might have Crohn’s or Colitis:
Upfront tests
1. We will collect a stool sample and blood sample and you will complete some questionnaires about your lifestyle, diet and the impact of your symptoms.
2. We will take additional biopsy samples during your diagnostic colonoscopy (an exploration of the bowel with a flexible camera) that you will have as part of your standard hospital care.
If you are not diagnosed with Crohn’s or Colitis
1. No further research visits are needed, but we would like to access your medical records later on to collect information on any Crohn’s or Colitis-related symptoms or conditions you may subsequently develop.
2. You will continue to be seen by the hospital for any NHS tests or follow-ups you need.
If you are diagnosed with Crohn’s or Colitis
1. We will collect stool samples and blood samples every three months for the first year and you will be given health questionnaires to complete.
2. We will repeat the above every 6 months for the second year.
3. You will have a follow-up colonoscopy after 1 year to check on the health of your bowel.
Taking part in the study will not impact the treatment you receive, however, if you are diagnosed with Crohn’s or Colitis you may have access to more frequent check-ups and enhanced access to your dedicated Crohn’s and Colitis team than if you didn’t take part.
What are the possible benefits and risks of participating?
The potential benefits are regular face-to-face reviews with experts highly experienced in the management of Crohn’s and Colitis and a faster diagnosis than in standard NHS practice. These study reviews can provide patients with access to support, knowledge and expertise at regular time points following diagnosis. In addition, if diagnosed with Crohn’s or Colitis, the implementation of regular tests which form part of the research study will provide information about how patients are responding to any treatments and potentially identify problems early. This includes a colonoscopy assessment 12 months after diagnosis to check on the health of the intestine, to check the response to treatment and to decide if any further changes to treatment should be made. The longer-term benefits of the Open-IBD study are for the wider Crohn’s and Colitis community rather than individual patients. This study will improve the understanding of the links between gut microbes, genes, diet and Crohn’s and Colitis. It also aims to identify how these factors influence an individual’s response to treatment. This study seeks to identify, at the time of diagnosis, which patients are likely to develop more complicated forms of the disease and to provide them with the most effective treatments early on.
The study involves the collection of blood and tissue samples. As with any medical procedure these carry small risks, but we minimise these by having them carried out by qualified and trained hospital staff. These procedures are standard practice whether patients join the study or not. Blood sampling can cause discomfort and may cause a small bruise. Tissue samples (biopsies) are taken as part of your routine clinical care and at the same time, some additional samples would be taken and used for the study. When a biopsy is taken, there is a small risk of bleeding (1 in 150 chance) and there is a very small risk that the procedure could create a hole in the bowel (perforation) (1 in 1500 chance).
Where is the study run from?
Newcastle Clinical Trials Unit (Newcastle University) (UK)
When is the study starting and how long is it expected to run for?
January 2024 to July 2029
Who is funding the study?
EMBL Enterprise Management Technology Transfer GmbH (Germany)
Who is the main contact?
Prof. Chris Lamb, christopher.lamb@newcastle.ac.uk
Contact information
Public
Newcastle Clinical Trials Unit
Newcastle University, Baddiley-Clark Building
Richardson Road
Newcastle upon Tyne
NE2 4AX
United Kingdom
| Phone | +44 (0)191 208 4870 |
|---|---|
| carol.shields@newcastle.ac.uk |
Scientific
Translational & Clinical Research Institute
Faculty of Medical Sciences
Newcastle University
Newcastle
NE2 4HH
United Kingdom
 ORCID ID |
0000-0002-7271-4956 |
|---|---|
| Phone | +44 (0) 191 208 7057 |
| christopher.lamb@newcastle.ac.uk |
Public
Newcastle Clinical Trials Unit
Newcastle University
Baddiley-Clark Building
Richardson Road
Newcastle upon Tyne
NE2 4AX
United Kingdom
| Phone | +44 (0)191 208 0654 |
|---|---|
| open.ibd@newcastle.ac.uk |
Public
Newcastle Clinical Trials Unit
Newcastle University
Baddiley-Clark Building
Richardson Road
Newcastle upon Tyne
NE2 4AX
United Kingdom
| Phone | +44 (0)191 208 0654 |
|---|---|
| open.ibd@newcastle.ac.uk |
Study information
| Study design | Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Open-IBD: a longitudinal multi-omics inception cohort in inflammatory bowel disease |
| Study acronym | Open-IBD |
| Study objectives | Study hypothesis not available, however, the overarching objective for the study is to recruit 1,000 IBD participants and up to 1,000 non-IBD control participants with the collection of clinical metadata (including disease activity and quality of life measures and environmental exposures), and biosamples for research. 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. |
| Ethics approval(s) | Approved 13/12/2024, Wales Research Ethics Committee 1 Cardiff (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)2922 940912, +44 (0)292 2940931; Wales.REC1@wales.nhs.uk), ref: 24/WA/0338 |
| Health condition(s) or problem(s) studied | Inflammatory bowel disease |
| Intervention | Open-IBD is a multi-centre, prospective, observational, inception cohort study of inflammatory bowel disease (comprising Crohn’s disease and ulcerative colitis) with approximately seven UK sites. The overall recruitment sample will comprise of two cohorts: 1. ‘IBD cohort’ = subjects with inflammatory bowel disease; anticipated 50:50 split between ulcerative colitis/inflammatory bowel disease unclassified (IBD-U) and Crohn’s disease. 2. ‘Non-IBD cohort’ = additional subjects referred to hospital with suspected IBD where investigations do not confirm IBD. Anticipated diagnoses in this group include but are not limited to microscopic colitis, coeliac disease, infective colitis, diverticulitis, colorectal cancer and irritable bowel syndrome. Patients will be identified by the gastroenterology teams and screened against the study eligibility criteria using the patient's medical records. Eligible patients will have the study explained to them by a member of the study team and be given the Participant Information Sheet for further information. Informed, written consent will be sought prior to any baseline data data collection. Participants will provide informed consent electronically, using an approach developed and used successfully for other studies. If preferred, participants can also complete informed consent and questionnaires in paper form. Some study assessments will be completed remotely, at participants' homes and some during hospital visits. Each participant will therefore be provided with access to an online database to complete questionnaires and track samples, the study database. All participants will be enrolled for approximately 48 months, with assessments done at baseline (prior to starting treatment). Once the diagnosis has been established participants will be allocated to either the ‘IBD cohort’ or the ‘Non-IBD cohort’. Participants allocated to the 'IBD cohort' will then have hospital visits at months 3, 6, 9, 12, 18 and 24. After month 24 visit there will not be any other hospital visits as part of this study. At months 36 and 48 research staff will collect data from participants' medical records only. Participants allocated to the 'non-IBD cohort' will not have any other hospital visits, following their baseline visit. The local research team will only collect data from their medical records at months 24, 36 and 48. The OPEN-IBD research team at site will be available to support and help with any questions or concerns about the study. |
| Intervention type | Other |
| Primary outcome measure | Recruitment of 2000 patients within 4 years: The number of recruited participants will be reported through the recruitment report generated at the end of the recruitment period. |
| Secondary outcome measures | 1. Clinical disease activity measured using the patient-reported outcome (PRO)-2 at baseline and months 3, 6, 9, 12, 18 and 24 2. Endoscopic disease activity measured using the ulcerative colitis endoscopic index of severity (UCEIS) or the Simple Endoscopic Score for Crohn’s Disease (SES-CD) at baseline and month 12 3. Patient report measure of disease control measured using IBD Control at baseline and months 3, 6, 9, 12, 18 and 24 |
| Overall study start date | 31/01/2024 |
| Completion date | 31/07/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 2000; UK Sample Size: 2000 |
| Key inclusion criteria | All patients must fulfil the following criteria to be enrolled in the study. 1. Suspected diagnosis of IBD i.e. referred to/presenting within hospital as part of the IBD diagnosis pathway, for example: 1.1. People being referred from primary care to secondary care with gastrointestinal symptoms and/or tests available in primary care suggestive of gastrointestinal pathology that may be due to inflammatory bowel disease e.g. a raised faecal calprotectin or faecal immunochemical test (FIT). 1.2. People being referred between or within or between secondary care specialties with test results or symptoms suggestive of gastrointestinal pathology that may be due to inflammatory bowel disease. 1.3. People identified in secondary care services to have radiological features of inflammatory bowel disease but where diagnostic lower gastrointestinal endoscopy has yet to happen or is not planned e.g. ileitis or perianal sepsis identified on cross-sectional imaging. 1.4. Patients presenting/admitted to hospital with suspected or confirmed new onset inflammatory bowel disease. 2. Adults aged 16 years and over 3. Willing and able to provide informed consent 4. Willing to undertake the following study procedures: 4.1. Completion of questionnaires 4.2. Collection of stool specimens at home 4.3. Provision of blood and biopsy samples during hospital visits |
| Key exclusion criteria | The following exclusion criteria apply: 1. Potential participants should not be currently receiving treatment with oral corticosteroids or an advanced therapy (biologic, JAKi or S1P receptor modulator) if commenced as treatment for suspected IBD. 1.1. The exception are patients admitted to hospital due to suspected new onset inflammatory bowel disease consistent with acute severe colitis (ASC) who have received 7 days or less of oral or intravenous corticosteroids or advanced IBD therapies. Research staff should aim to approach potentially suitable patients early to facilitate obtaining endoscopic biopsies if possible and minimise the duration of treatment exposure prior to obtaining biosamples. For the avoidance of doubt, the first day of prescribed corticosteroids or advanced therapy will count as day 0. 1.2. Receipt of corticosteroids or an advanced therapy at the time of enrolment, for an indication other than inflammatory bowel disease, including psoriasis, uveitis, axial spondyloarthritis, autoimmune liver disease or microscopic colitis is not an exclusion. 2. Participants who have already undergone diagnostic lower GI endoscopy will be excluded unless a further endoscopic procedure is planned/likely where treatment-naïve biopsies could be collected or the disease is beyond the reach of diagnostic endoscopy. 2.1. The exception are patients who are recruited as inpatients with acute severe colitis (ASC) and have already undergone a colonoscopy or flexible sigmoidoscopy. These patients may be enrolled provided they meet the remainder of the eligibility criteria irrespective of whether a lower gastrointestinal endoscopy has been performed or not. 3. Presence of a stoma. |
| Date of first enrolment | 10/03/2025 |
| Date of final enrolment | 31/12/2028 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Newcastle upon Tyne
NE1 4LP
United Kingdom
London
E1 1FR
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Edinburgh
Lothian
EH4 2XU
United Kingdom
London
SE1 9RT
United Kingdom
Exeter
EX2 5DW
United Kingdom
London
SW17 0RE
United Kingdom
Sponsor information
Hospital/treatment centre
Freeman Hospital
Freeman Road
High Heaton
Newcastle-Upon-Tyne
NE7 7DN
England
United Kingdom
| Phone | +44 (0)191 28 26774 |
|---|---|
| Tnu-tr.Sponsormanagement@nhs.net | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Publication is planned in high-impact peer-reviewed journals and the study findings will be published during the study follow-up and it is anticipated for several years afterwards due to the volume and value of data and samples collected. The results of the study will be made available on the Open-IBD website. Additionally, lay summaries of results will be made available to participants and members of the national patient group (Crohn's & Colitis UK) upon publication of results. When appropriate, study findings will be presented by the study team at national and international conferences. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
27/01/2025: Study's existence confirmed by the NIHR.
