Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03282903
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : December 19, 2020
Sponsor:
Collaborators:
University of Aberdeen
The Wellcome Trust Sanger Institute
NHS Lothian
Chief Scientist Office of the Scottish Government
Crohn's and Colitis in Childhood
Cure Crohn's and Colitis
Edinburgh and Lothain Health Fund (Lothian Health Board)
Information provided by (Responsible Party):
University of Edinburgh

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.

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.


Condition or disease
Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 3100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Crohn's disease patients
1550 Crohn's disease patients who are symptomatically controlled.
Ulcerative Colitis patients
1550 Ulcerative Colitis patients who are symptomatically controlled.



Primary Outcome Measures :
  1. 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?"



Secondary Outcome Measures :
  1. 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
Stool sample (for microbiome analysis) Saliva sample (for genomic analysis) Blood sample (for biochemical, haematological and genomic analysis)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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


Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Charlie Lees charlie.lees@ed.ac.uk
Contact: Lisa M Derr predicct@ed.ac.uk

Locations
Show Show 41 study locations
Sponsors and Collaborators
University of Edinburgh
University of Aberdeen
The Wellcome Trust Sanger Institute
NHS Lothian
Chief Scientist Office of the Scottish Government
Crohn's and Colitis in Childhood
Cure Crohn's and Colitis
Edinburgh and Lothain Health Fund (Lothian Health Board)
Investigators
Layout table for investigator information
Principal Investigator: Charlie Lees University of Edinburgh
Layout table for additonal information
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03282903    
Other Study ID Numbers: 16/WM/0152
IRAS183889 ( Other Identifier: IRAS )
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Anonymised data will be shared with collaborators to allow analysis.

Only aggregate level data will be published.


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases