The PRognostic Effect of Environmental Factors in Crohn's and Colitis (PREdiCCt)
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|ClinicalTrials.gov Identifier: NCT03282903|
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : December 19, 2020
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;-
- 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.
- Participants will attend a clinic visit for routine tests and also to complete several questionnaires with a research nurse.
- 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.
- 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.
- 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;-
- Finding out the environmental and dietary factors for patients to avoid because they trigger flare.
- Finding out behaviours for patients to adopt because they bring about remission.
- Finding out what the microorganisms that predict flare look like.
- Gaining information which helps future studies aimed at finding better diets for IBD sufferers.
- 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.
|Condition or disease|
|Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis|
|Study Type :||Observational|
|Estimated Enrollment :||3100 participants|
|Official Title:||The PRognostic Effect of Environmental Factors in Crohn's and Colitis|
|Actual Study Start Date :||November 1, 2016|
|Estimated Primary Completion Date :||March 16, 2021|
|Estimated Study Completion Date :||March 16, 2021|
Crohn's disease patients
1550 Crohn's disease patients who are symptomatically controlled.
Ulcerative Colitis patients
1550 Ulcerative Colitis patients who are symptomatically controlled.
- Clinical flare [ Time Frame: Up to 2 years ]
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?"
- Hard clinical flare [ Time Frame: Up to 2 years ]Clinical flare (primary outcome) plus commencement of any new medication; altered dosing of existing medication for the treatment of IBD flare, with an increase in CRP (>5mg/L) and / or faecal calprotectin (>200mcg/g).
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282903
|Contact: Charlie Leesemail@example.com|
|Contact: Lisa M Derrfirstname.lastname@example.org|
|Principal Investigator:||Charlie Lees||University of Edinburgh|