The PRognostic Effect of Environmental Factors in Crohn's and Colitis
PREdiCCt
2 other identifiers
observational
2,629
1 country
41
Brief Summary
The PREdiCCt Study: This is a major study that is now being launched. This is the first study of its kind and is specifically directed toward understanding how environmental factors and the gut microorganisms influence IBD flare and recovery. For the PREdiCCt study, the investigators hope to recruit 3100 people in remission from Crohn's disease or ulcerative colitis (illness under control) from 28 inflammatory bowel disease clinics across the UK. The investigators hope to conduct the study in the following stages;-
- 1.Patients with Crohn's disease, ulcerative colitis or inflammatory bowel disease unclassified (IBDU) in clinical remission (under control) will be approached in gastroenterology clinics across the country and invited to take part in the PREdiCCt study. Alternatively they will express their interest in the study after seeing PREdiCCt promotional leaflets/posters/videos/social media.
- 2.Participants will attend a clinic visit for routine tests and also to complete several questionnaires with a research nurse.
- 3.At home over the next week participants will complete detailed questionnaires assessing their environment and diet. Participants will also collect a stool and saliva sample and send this to our laboratories (the investigators have developed easy ways of doing this reliably by post). The stool sample is to analyse the microorganisms in the participant's gut and the saliva is used to analyse their DNA. In addition to this the participants are asked to complete a 4-day weighed food diary. The food diary is sent to the University of Aberdeen for analysis.
- 4.Investigators will then follow patients' progress over 24 months. They will be asked to complete a short questionnaire every month with a longer questionnaire after 12 months and culminating in a final questionnaire 24 months after their initial clinic visit.
- 5.If a participant experiences a flare, investigators will collect an additional stool sample; but most importantly investigators will look to see how the environmental and microorganism factors recorded at the beginning differ for those that flare up versus those that don't.
- 6.Finding out the environmental and dietary factors for patients to avoid because they trigger flare.
- 7.Finding out behaviours for patients to adopt because they bring about remission.
- 8.Finding out what the microorganisms that predict flare look like.
- 9.Gaining information which helps future studies aimed at finding better diets for IBD sufferers.
- 10.Developing ways of gathering information online from IBD patients about their well-being that doctors can routinely use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2016
Longer than P75 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 12, 2017
CompletedFirst Posted
Study publicly available on registry
September 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2022
CompletedMay 20, 2024
May 1, 2024
3.4 years
September 12, 2017
May 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical flare
Patients will be asked to answer a monthly follow up, providing details of their IBD over the last month. A clinical flare will be determined by a patient answering "no" to the following question in the monthly follow up: "Do you think your disease has been well controlled in the past 1 month?"
Up to 2 years
Secondary Outcomes (1)
Hard clinical flare
Up to 2 years
Study Arms (2)
Crohn's disease patients
1550 Crohn's disease patients who are symptomatically controlled.
Ulcerative Colitis patients
1550 Ulcerative Colitis patients who are symptomatically controlled.
Eligibility Criteria
IBD patients with a confirmed diagnosis of Crohn's Disease, Ulcerative Colitis or IBD unspecified, who are in clinical remission, \>6 since diagnosis, \>2 months since any change in therapy for Crohn's disease, ulcerative colitis or IBDU, aged 6 or over at study entry and who informed consent can be obtained from (or parent/guardian).
You may qualify if:
- \- Confirmed Crohn's disease or ulcerative colitis or IBDU (Lennard-Jones/Porto criteria).
- Clinical remission (see definition Section 3.2 of protocol) \>6 months since diagnosis with Crohn's disease, ulcerative colitis or IBDU \>2 months since any change in therapy for Crohn's disease, ulcerative colitis or IBDU Aged six years or over at study entry Written informed consent obtained from patient or parent / guardian
You may not qualify if:
- \- Patient unwilling to take part in all aspects of the study Unable to obtain written informed consent Systemic corticosteroids (oral or intravenous) within the last two months Thiopurines / methotrexate / biologic therapy started in the preceding two months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- University of Aberdeencollaborator
- Wellcome Sanger Institutecollaborator
- NHS Lothiancollaborator
- Chief Scientist Office of the Scottish Governmentcollaborator
- Crohn's and Colitis in Childhoodcollaborator
- Cure Crohn's and Colitiscollaborator
- Edinburgh and Lothain Health Fund (Lothian Health Board)collaborator
Study Sites (41)
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Bronglais General Hospital
Aberystwyth, United Kingdom
NHS Lanarkshire
Airdrie, United Kingdom
Ulster Hospital
Belfast, BT16 1RH, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
West Suffolk NHS Foundation Trust
Bury St Edmunds, United Kingdom
Cambridge Addenbrooke's Hospital
Cambridge, United Kingdom
Glangwili General Hospital
Carmarthen, United Kingdom
University Hospital Coventry & Warwickshire
Coventry, United Kingdom
Darlington Memorial Hospital
Darlington, United Kingdom
Ninewells Hospital
Dundee, DD2 1UB, United Kingdom
Eastbourne General Hospital
Eastbourne, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Royal Hospital for Sick Children,Edinburgh
Edinburgh, EH9 1LF, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Queen Elizabeth Hospital
Gateshead, United Kingdom
Glasgow Royal Infirmary
Glasgow, G4 0SF, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Royal Hospital for Children, Glasgow
Glasgow, G51 4TF, United Kingdom
Withybush General Hospital
Haverfordwest, United Kingdom
Raigmore Hospital
Inverness, IV2 3UJ, United Kingdom
Kettering General Hospital NHS Foundation Trust
Kettering, United Kingdom
Queen Elizabeth King's Lynn
Kings Lynn, United Kingdom
Kingston Hospital
Kingston upon Thames, United Kingdom
NHS Fife
Kirkcaldy, United Kingdom
NHS Forth Valley
Larbert, United Kingdom
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, United Kingdom
St John's Hospital
Livingston, EH54 6PP, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Royal Free Hospital
London, United Kingdom
Royal London Hospital (Barts Health)
London, United Kingdom
Newcastle Royal Victoria Hospital
Newcastle, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Royal Berkshire Hospital
Reading, United Kingdom
Salford Royal Hospital
Salford, United Kingdom
Sandwell and West Birmingham Hospitals NHS Trust
Sandwell, United Kingdom
Buckinghamshire Healthcare NHS Trust
Stoke Mandeville, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom
Pinderfield General Hospital
Wakefield, United Kingdom
Warrington and Halton NHS FT
Warrington, United Kingdom
Royal Hampshire Hospital
Winchester, United Kingdom
Related Publications (1)
Constantine-Cooke N, Gros B, Plevris N, Williams LJ, Jones GR, Kyle J, Kennedy NA, Velasco-Pardo V, Rudge A, Alexander D, Anderson CA, Brusco de Freitas M, Derr LM, Derikx LA, Gilchrist S, Henderson P, Horgan GW, Irving P, Lamb CA, Jostins-Dean L, Lindsay JO, MacDonald J, Mowat C, Murray C, Parkes M, Siakavellas SI, Vallejos CA, Gaya DR, Rhodes JM, Johnstone AM, Weir CJ, Lees CW; PREdiCCt study group. Associations between demographic, clinical and dietary factors and flares in inflammatory bowel disease: the PRognostic effect of Environmental factors in Crohn's and Colitis (PREdiCCt) prospective cohort study. Gut. 2026 Jan 19:gutjnl-2025-337846. doi: 10.1136/gutjnl-2025-337846. Online ahead of print.
PMID: 41554630DERIVED
Biospecimen
Stool sample (for microbiome analysis) Saliva sample (for genomic analysis) Blood sample (for biochemical, haematological and genomic analysis)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charlie Lees
University of Edinburgh
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2017
First Posted
September 14, 2017
Study Start
November 1, 2016
Primary Completion
March 20, 2020
Study Completion
March 20, 2022
Last Updated
May 20, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share
Anonymised data will be shared with collaborators to allow analysis. Only aggregate level data will be published.