Exploring detailed patient-specific biological analyses to personalise treatment in inflammatory bowel disease

Not Applicable

• Conditions: Inflammatory Bowel Disease; Digestive System; Crohn’s disease, ulcerative colitis

• Registration Number: ISRCTN65030013
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-23
• Last Update Posted: 5 August 2022
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 468

Inclusion Criteria

1. Healthy control patients:
1.1. =18 years-old
1.2. Willing to consent to sample collection
1.3. No prior diagnosis or current clinical suspicion of IBD

2. Inflammatory bowel disease patients, including ulcerative colitis, Crohn’s disease and IBD-unclassified
2.1. Active disease as determined by standard clinical parameters measured within the 2 months prior to recruitment:
- Crohn's symptom flare as indicated by Harvey-Bradshaw score >5 or unweighted PRO-2 (CD) of average daily stool stool frequency (SF) score =4 and/or average daily abdominal pain (AP) score =2,
- faecal calprotectin =250micrograms/gram;
OR
- UC / IBD-U symptom flare as indicated by PRO-2 (UC) of =3 including a rectal bleeding score of =1,
- faecal calprotectin =250micrograms/gram.

3. Able to consent to the study (with interpreter, if required)

Exclusion Criteria

Unable or unwilling to provide informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to medication will be determine by a combination of faecal calprotectin level and patient reported outcome (PRO)-2 score (for either Crohn's disease or ulcerative colitis) at weeks 10-14 and weeks 28-32, compared to pre-treatment levels.

Secondary Outcome Measures

Name	Time	Method
1. Prevalence of psychiatric comorbidity and quality of life disruption in patients with active IBD measured using validated questionnaires at baseline<br>2. Changes in psychiatric comorbidity and quality of life related to new IBD medications using longitudinal completion of questionnaires at weeks 10-14 and weeks 28-32<br>3. Prevalence and treatment-induced changes in nutritional status in patients with active IBD measured using hand grip strength and bioimpedance at baseline, weeks 10-14 and weeks 28-32.