NCT03282903: PREdiCCt

The PRognostic Effect of Environmental Factors in Crohn's and Colitis

Completed Last updated 20 May 2024

What this trial tests

trial in Inflammatory Bowel Diseases in 2,629 participants. Completed in 20 March 2022.

Timeline

1 November 2016

Primary endpoint
20 March 2020

20 March 2022

Quick facts

Lead sponsor	University of Edinburgh
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,629
Start date	1 November 2016
Primary completion	20 March 2020
Estimated completion	20 March 2022
Sites	41 locations across United Kingdom

Conditions studied

• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
• Crohn Disease — all drugs for Crohn Disease →
• Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

University of Edinburgh

Who can join

6 and older, any sex, with Inflammatory Bowel Diseases or Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

What investigators hope to achieve;-

1. Finding out the environmental and dietary factors for patients to avoid because they trigger flare.
2. Finding out behaviours for patients to adopt because they bring about remission.
3. Finding out what the microorganisms that predict flare look like.
4. Gaining information which helps future studies aimed at finding better diets for IBD sufferers.
5. Developing ways of gathering information online from IBD patients about their well-being that doctors can routinely use.

The investigators have assembled expert doctors, epidemiologists, microbiologists, nutrition scientists, and bioinformaticians. These experts will use the systems the investigators have put in place to make sure PREdiCCt succeeds. It will yield a lot of new information to help sufferers right away; but the information will also help to kick start many important future studies that will bring us ever closer to a cure for Crohn's disease and ulcerative colitis.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Early Diagnosis, Early Stratification, and Early Intervention to Deliver Precision Medicine in IBD.
   Noor NM, Sousa P, Paul S, Roblin X. · · 2022 · cited 48× · PMID 34480558 · DOI 10.1093/ibd/izab228
2. An Insight into Patients' Perspectives of Ulcerative Colitis Flares via Analysis of Online Public Forum Posts.
   Rubin DT, Torres J, Dotan I, Xu LT, et al · · 2024 · cited 5× · PMID 37934789 · DOI 10.1093/ibd/izad247
3. 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.
   Constantine-Cooke N, Gros B, Plevris N, Williams LJ, et al · · 2026 · PMID 41554630 · DOI 10.1136/gutjnl-2025-337846