TRansabdominal UltraSonography of the bowel To monitor disease activity in Subjects with Ulcerative Colitis

TRansabdominal UltraSonography of the bowel To monitor disease activity in Subjects with Ulcerative Colitis - TRUST & UC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00008990

Enrollment

400

Registered

2015-10-01

Start date

2015-11-16

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

K51.9

Interventions

Group 1: At each visit the following data will be collected: anamnesis, SCCAI, US parameters at involved areas except rectum (bowel wall thickness, bowel wall stratification, duplex US), medication,

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients = 18 years - Patients with a proven diagnosis of proctosigmoiditis, left-sided colitis or pancolitis and currently at relapse (SCCAI = 5)

Exclusion criteria

Exclusion criteria: - Patients having disease limited to the rectum (ulcerative proctitis) - Pregnancy - Patients with ileal stoma or ileoanal pouch - Infectious colitis (e.g. CMV, C. diff.) - Preparation for colonoscopy at day of US examination or the day before - Patients not capable of signing written consent

Design outcomes

Secondary

Measure	Time frame
- the correlation of calprotectin with clinical response - the correlation of CRP with clinical response - the change of US parameters (e.g. bowel wall thickness, bowel wall stratification, mesenteric proliferation, lymphnodes) in patients with clinical response at week 6 and/or week 12. - the change of US parameters (e.g. bowel wall thickness, bowel wall stratification, mesenteric proliferation, lymphnodes) in patients with clinical remission at week 6 and/or week 12 - does sonographic non-response at week 6 in patients with clinical response at week 6 predict early relapse before or by week 12? - the correlation of calprotectin with US parameters (e.g. bowel wall thickness, bowel wall stratification, mesenteric proliferation, lymphnodes) at week 6 and/or week 12	—

Measure

Time frame

- the correlation of calprotectin with clinical response - the correlation of CRP with clinical response - the change of US parameters (e.g. bowel wall thickness, bowel wall stratification, mesenteric proliferation, lymphnodes) in patients with clinical response at week 6 and/or week 12. - the change of US parameters (e.g. bowel wall thickness, bowel wall stratification, mesenteric proliferation, lymphnodes) in patients with clinical remission at week 6 and/or week 12 - does sonographic non-response at week 6 in patients with clinical response at week 6 predict early relapse before or by week 12? - the correlation of calprotectin with US parameters (e.g. bowel wall thickness, bowel wall stratification, mesenteric proliferation, lymphnodes) at week 6 and/or week 12

—

Primary

Measure	Time frame
The primary endpoint is the decrease of bowel wall thickening in patients with clinical response at week 6 and/or week 12.	—

Countries

Germany

Contacts

Public ContactAlexander Rössler

AbbVie Deutschland GmbH & Co. KG, Medical Development

alexander.roessler@abbvie.com015114037106

Outcome results

None listed

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