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NCT07920367Not yet recruiting

Non-Invasive Biomarker Monitoring in UC on Biologics

Prospective Evaluation of Faecal and Urinary Volatile Organic Compounds as Non-Invasive Biomarkers for Therapeutic Drug Monitoring and Disease Activity in Ulcerative Colitis Patients Receiving Intravenous Biologic Therapy

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

Ulcerative colitis (UC) is a long-term inflammatory bowel condition. Many patients are treated with intravenous biologic drugs such as infliximab or vedolizumab. Measuring the level of these drugs in the blood helps doctors adjust treatment, but results can take one to two weeks to come back. Volatile organic compounds (VOCs) are gases released from stool and urine that reflect activity in the gut, including gut bacteria and inflammation. They can be measured quickly and without needles. This study will find out whether VOCs in stool and urine can tell apart patients with adequate drug levels from those with low drug levels. It will also look at whether VOCs can identify patients whose UC is in remission versus those whose disease is flaring, and how VOCs relate to blood inflammation markers, gut bacteria and DNA methylation (chemical tags on genes). Adults with UC already receiving maintenance intravenous infliximab or vedolizumab at University Hospitals Coventry and Warwickshire will be invited to take part. Participants will provide stool, urine and blood samples at four of their routine infusion appointments. No extra visits are needed and treatment is not changed by the study.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
99 (estimated)
First submitted
30 Oct 2026
Start date
18 Nov 2026
Primary completion date
8 Sept 2027
Lead sponsor
University Hospitals Coventry and Warwickshire NHS Trust
NCT number
NCT07920367

What you commit to

  • Study type: Observational
  • Planned participants: 99
  • From 18 Nov 2026 to the primary completion date, 8 Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant cytotoxic chemotherapy

Other illness

  • Active malignancy

Other

  • Pregnancy or lactation
  • Antibiotic use within the preceding 4 weeks

Who the study is looking for

  • Age 18 years or older
  • Confirmed diagnosis of ulcerative colitis (clinical, endoscopic and histological criteria per ECCO guidelines)
  • Established on maintenance intravenous infliximab or vedolizumab
  • Attending the day unit for routine maintenance intravenous infusion

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospitals Coventry and Warwickshire NHS Trust
Coordinator of this site? Confirm its status
CoventryUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.