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

Therapy Personalisation using Multiomic Analyses in Inflammatory Bowel Disease – THAMES-IBD

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN65030013

Enrollment

468

Registered

2022-06-23

Start date

2022-06-01

Completion date

Unknown

Last updated

2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease Digestive System Crohn’s disease, ulcerative colitis

Interventions

This will be a prospective, multi-site observational cohort study, in order to gain ‘real world’ evidence that is then applicable to standard practice across a range of institutions. All patients who

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Unable or unwilling to provide informed consent

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Prevalence of psychiatric comorbidity and quality of life disruption in patients with active IBD measured using validated questionnaires at baseline 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 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.	—

Measure

Time frame

1. Prevalence of psychiatric comorbidity and quality of life disruption in patients with active IBD measured using validated questionnaires at baseline 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 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.

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026