The PREdiCCt Study: the prognostic effect of environmental factors in Crohn’s and colitis

Not Applicable

Completed

• Conditions: Inflammatory bowel disease; Digestive System

• Registration Number: ISRCTN67248113
• Lead Sponsor: ACCORD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-11
• Study Completion: 2022-12-31
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3100

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.