Condition category
Digestive System
Date applied
29/08/2016
Date assigned
11/05/2017
Last edited
11/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Inflammatory bowel disease (IBD) is a term used to describe conditions which cause long-term (chronic) inflammation (swelling) in the digestive tract (gut), and includes Crohn’s Disease and Ulcerative Colitis. It can make sufferers quite weak lacking energy and enthusiasm, typically giving them abdominal pain, bloody diarrhoea and nausea. The symptoms can be extreme enough to affect all aspects of day-to-day living. This can mean that sufferers don’t do so well at school or in the workplace, can be more socially isolated and as a result can suffer increasing levels of anxiety and depression. There is currently no cure for these conditions, and so the main aim of treatment is to reduce the symptoms (remission) and prevent the disease from “flaring up” and becoming active again. There are a range of treatments however many have toxic side effects which often outweigh the benefits. The response to the various treatments can be variable and sometimes what will work in one person won’t work in others. In addition a drug can work for a period of time and then stop working. In some patients the side effects are such that they are unable to tolerate that particular treatment. All too often sufferers need major surgery - more than 50% with Crohn’s disease and 15-30% with ulcerative colitis. In recent years, researchers have gained a better understanding of the underlying causes of IBD. For example, a person’s genetic makeup is thought to play a role in why people get IBD, but cannot be used to predict if a patient’s IBD will be mild or severe or what causes flare ups. It has also been found that the bacteria that live in the gut (microorganisms) are different in patients with IBD, but it is not known whether these different microorganisms cause IBD or are caused by IBD’s gut inflammation. It is possible that environmental factors (infections, drugs, and dietary factors) play an important role, probably by altering the gut microorganisms, but this has not yet been proven. The aim of this study is to investigate how environmental factors and the gut microorganisms influence IBD flare and recovery.

Who can participate?
Patients with inflammatory bowel disease who are in remission and aged 6 years and over

What does the study involve?
Participants 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. They will also collect a stool and saliva sample and send this to our laboratories (we’ve 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. Participants are then followed up monthly over the next 24 months using short questionnaires completed online. They also complete a longer questionnaire after 12 months and 24 months. If a participant experiences a flare up, an additional stool sample is collected in order to how the environmental and microorganism factors recorded at the beginning differ for those that flare up versus those that don’t.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
Western General Hospital (UK)

When is the study starting and how long is it expected to run for?
June 2016 to January 2019

Who is funding the study?
Chief Scientist Office (UK)

Who is the main contact?
Dr Adam Wilson
adam.wilson@ed.ac.uk

Trial website

http://www.predicct.co.uk/

Contact information

Type

Public

Primary contact

Dr Adam Wilson

ORCID ID

Contact details

Edinburgh Clinical Trials Unit
Rm D75 2nd Floor OPD
Western General Hospital
Crewe Road South
Edinburgh
EH4 2XU
United Kingdom
+44 131 537 2562
adam.wilson@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 2

Study information

Scientific title

The PRognostic effect of Environmental factors in Crohn’s and Colitis

Acronym

PREdiCCt

Study hypothesis

The aim of this study is to establish which environmental and microbial factors are associated with disease flare.

Ethics approval

NRES Committee – The Black Country, 22/03/2016, ref: 16/WM/0152

Study design

Observational longitudinal study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Other

Trial type

Prevention

Patient information sheet

http://www.predicct.co.uk/uploads/4/6/6/0/4660963/information_leaflet_v1_11.02.16.pdf

Condition

Irritable bowel disease

Intervention

Patients will be approached at routine clinic visits to invite them to participate in PREdiCCt. Following written informed consent, the clinical team will be asked provide information relating to the patients current disease status, demographic, phenotyping and medical information which will include taking blood for routine testing. No further visits to clinic for PREdiCCt are required.

Within the first week of recruitment into PREdiCCt patients will also be asked to provide a saliva sample (for genomic DNA) and a stool sample (for bacterial DNA, SCFA and faecal calprotectin) along with completion of a baseline questionnaire to collect information relating to their environment, lifestyle, and habitual diet via a custom designed web portal from home.

All patients are followed for a minimum of 24 months during which, on a monthly basis, they are asked to complete a short questionnaire relating to their symptoms, environment and lifestyle through the web portal. If a patient experiences a flare in their condition they will be asked to provide another stool sample and will continue to be followed up. Multiple endpoints can be reached by an individual during the course of follow-up however only the first endpoint reached will be used in the primary analysis. At the end of the 24 month follow up period a final questionnaire will be requested.

Intervention type

Phase

Drug names

Primary outcome measures

Evidence of clinical flare determined by the patient answering “no” to the following question “Do you think your disease has been well controlled in the past 1 month?” at baseline and then monthly for 24 months.

Secondary outcome measures

Medication status will be reported by the patient directly (via a secure web portal) on a monthly basis for 24 months. Patients will be asked to record any changes to their drug regimen including dose alteration, addition of new medication, stop of medication.

Overall trial start date

01/06/2016

Overall trial end date

01/01/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Confirmed Crohn’s disease or ulcerative colitis or IBDU (Lennard-Jones/Porto criteria) 59-60.
2. Clinical remission
3. More than 6 months since diagnosis with Crohn’s disease, ulcerative colitis or IBDU
4. More than 2 months since any change in therapy for Crohn’s disease, ulcerative colitis or IBDU
5. Aged six years or over at study entry
6. Written informed consent obtained from patient or parent/guardian

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

1500

Participant exclusion criteria

1. Patient unwilling to take part in all aspects of the study
2. Unable to obtain written informed consent
3. Systemic corticosteroids (oral or intravenous) within the last two months
4. Thiopurines / methotrexate / biologic therapy started in the preceding two months

Recruitment start date

30/09/2016

Recruitment end date

01/09/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom

Sponsor information

Organisation

ACCORD

Sponsor details

Research Governance & QA Office
University of Edinburgh
The Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16
United Kingdom

Sponsor type

University/education

Website

accord.scot

Funders

Funder type

Government

Funder name

Chief Scientist Office

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

Intention to publish date

31/12/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes