The PREdiCCt Study: the prognostic effect of environmental factors in Crohn’s and colitis
| ISRCTN | ISRCTN67248113 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67248113 |
| Secondary identifying numbers | Version 2 |
- Submission date
- 29/08/2016
- Registration date
- 11/05/2017
- Last edited
- 13/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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?
University of Edinburgh (UK)
When is the study starting and how long is it expected to run for?
June 2016 to December 2022
Who is funding the study?
Chief Scientist Office (UK)
Who is the main contact?
Lisa Derr
lisa.derr@ed.ac.uk
Contact information
Public
Edinburgh Clinical Trials Unit (ECTU)
Nine BioQuarter Room D.02.11
Little France Road
Edinburgh
EH16 4UX
United Kingdom
| Phone | +44 (0)131 651 9918 |
|---|---|
| lisa.derr@ed.ac.uk |
Study information
| Study design | Observational longitudinal study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | http://www.predicct.co.uk/uploads/4/6/6/0/4660963/information_leaflet_v1_11.02.16.pdf |
| Scientific title | The PRognostic effect of Environmental factors in Crohn’s and Colitis |
| Study acronym | PREdiCCt |
| Study objectives | The aim of this study is to establish which environmental and microbial factors are associated with disease flare. |
| Ethics approval(s) | NRES Committee – The Black Country, 22/03/2016, ref: 16/WM/0152 |
| Health condition(s) or problem(s) studied | Inflammatory 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 | Other |
| Primary outcome measure | 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 study start date | 01/06/2016 |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 3100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/09/2016 |
| Date of final enrolment | 31/12/2019 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Gartnavel Royal Hospital
1055 Great Western Road Glasgow
Glasgow
G12 0XH
United Kingdom
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
Clepington Road
Dundee
DD3 8EA
United Kingdom
17 Old Edinburgh Road
Inverness
IV2 3HG
United Kingdom
Hamilton
ML3 0TA
United Kingdom
Dundonald
Belfast
BT16 1RH
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Whitechapel
London
E1 1BB
United Kingdom
Hayfield Road
Kirkcaldy
KY2 5AH
United Kingdom
Dudley Road
Birmingham
B18 7QH
United Kingdom
Stirling
FK8 1DX
United Kingdom
King's Lynn
PE30 4ET
United Kingdom
Whielden Street
Amersham
HP7 0JD
United Kingdom
Taunton
TA1 5DA
United Kingdom
Pinderfields General Hospital
Aberford Road
Wakefield
WF1 4EE
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Kingston upon Thames
KT2 7QB
United Kingdom
Sherriff Hill
Gateshead
NE9 6SX
United Kingdom
Winchester
SO22 5DG
United Kingdom
De Crespigny Park
Denmark Hill
London
SE5 8AB
United Kingdom
Caradoc Road
Aberystwyth
SY23 1ER
United Kingdom
Marlborough Street
Bristol
BS2 8HW
United Kingdom
Haverfordwest
SA61 2PZ
United Kingdom
Eccles
Salford
M6 8HD
United Kingdom
Hardwick Lane
Bury St. Edmunds
IP33 2QZ
United Kingdom
Kings Drive
Eastbourne
BN21 2UD
United Kingdom
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Lovely Lane
Warrington
WA5 1QG
United Kingdom
London Road
Reading
RG1 5AN
United Kingdom
Kettering
NN16 8UZ
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
Carmarthen
SA31 2AF
United Kingdom
Newcastle upon Tyne
NE1 4LP
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Watford Road
Harrow
HA1 3UJ
United Kingdom
Guildford
GU2 7XX
United Kingdom
Gorleston
Great Yarmouth
NR31 6LA
United Kingdom
Tooting
London
SW17 0QT
United Kingdom
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
Fazakerley Hospital
Lower Lane
Liverpool
L9 7AL
United Kingdom
Sponsor information
University/education
Research Governance & QA Office
University of Edinburgh
The Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16
Scotland
United Kingdom
| Website | accord.scot |
|---|---|
"ROR" |
https://ror.org/01x6s1m65 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | Data will be held at https://datashare.is.ed.ac.uk/ and applications to access data will be reviewed on an individual basis. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/12/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2021 to 31/12/2022.
2. The intention to publish date was changed from 31/12/2022 to 31/03/2023.
3. The plain English summary was updated to reflect these changes.
4. The trial participating centres were added.
29/10/2018: The following changes were made:
1. The recruitment end date was updated from 01/09/2018 to 31/12/2019.
2. The overall trial end date was updated from 31/05/2020 to 31/12/2021.
3. The intention to publish date was updated from 31/05/2021 to 31/12/2022.
12/09/2018: IPD sharing statement added.
02/08/2018: The following changes were made to the trial record:
1. The study contact was changed.
2. The target number of participants was changed from 1500 to 3100.
3. The overall trial end date was changed from 01/01/2019 to 31/05/2020.
