Ulcerative ColitisVIBRANTNCT07920367
Non-Invasive Biomarker Monitoring in UC on Biologics
An observational study of Ulcerative Colitis, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- Type of treatment
- Injection or infusion
- How many people
- 99 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Nov 2026to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (aged 18 years or older) with ulcerative colitis, confirmed by clinical, endoscopic and histological criteria, who are established on maintenance intravenous biologic therapy (infliximab or vedolizumab) and attend the medical day unit at University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK, for routine infusions. Eligible patients are identified by weekly screening of day unit infusion lists.
Who may be able to join
- 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
Who cannot join
- Pregnancy or lactation
- Antibiotic use within the preceding 4 weeks
- Active malignancy
- Concomitant cytotoxic chemotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ramesh Arasaradnam, FRCP, PhD contact
United Kingdom1 site
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, CV2 2DX
Maria Truslove, +44 024 7696 6053, researchsponsorship@uhcw.nhs.uk
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
Design: Single-centre, prospective, longitudinal observational cohort study at University Hospitals Coventry and Warwickshire NHS Trust (UHCW), UK. No intervention is assigned; participants continue standard-care maintenance intravenous biologic therapy.
Population: Adults (≥18 years) with ulcerative colitis (UC), confirmed by clinical, endoscopic and histological criteria per ECCO guidelines, established on maintenance intravenous infliximab or vedolizumab and attending the UHCW medical day unit. Patients in the induction phase are not eligible. Target enrolment is 99 participants.
Procedures: Participants are assessed at four consecutive routine infusion visits (every 4, 6 or 8 weeks; follow-up 12-24 weeks). At each visit, pre-infusion blood is taken for biologic trough concentration, anti-drug antibodies, C-reactive protein (CRP), full blood count, cytokines (IL-6, IL-10, IL-23) and DNA methylation. Stool and urine are collected at home before the visit. Stool is used for faecal calprotectin (FCP), VOC analysis and whole-genome shotgun metagenomic sequencing; urine is used for VOC analysis. Research samples are stored at -80 °C at the Arden Tissue Bank, UHCW, and VOC analysis is performed at the University of Warwick.
Classification: Trough concentrations are classified as sub-therapeutic at ≤1 µg/mL for infliximab and <12.7 µg/mL for vedolizumab, according to the reporting laboratories' thresholds, fixed before any VOC analysis. Remission is defined as FCP <250 µg/g and CRP ≤10 mg/L; relapse as FCP ≥250 µg/g and/or CRP >10 mg/L, or corticosteroid rescue, biologic dose escalation, or hospitalisation for UC flare (STRIDE-II).
Analysis: The primary analysis uses one baseline sample per participant. A pre-specified set of supervised machine-learning classifiers will be evaluated using nested cross-validation stratified by trough status and biologic agent, with feature selection and tuning confined to training folds. The primary outcome is cross-validated AUROC (95% CI); the hypothesis is supported if the lower 95% CI bound exceeds 0.5, with AUROC ≥0.70 considered acceptable. The urinary VOC analysis is tested in fixed sequence after the primary analysis. False discovery rate correction is applied to multi-VOC association analyses. Repeated-visit analyses use participant-grouped cross-validation.
Sample size: 77 participants (23 sub-therapeutic, 54 therapeutic) provide 80% power at two-sided α=0.05 to detect AUROC 0.70 versus 0.50 (Hanley-McNeil), assuming 30% sub-therapeutic. Allowing 20% attrition, 99 participants will be recruited.
- Conditions
- Ulcerative Colitis
- Keywords
- Volatile organic compounds, Therapeutic drug monitoring, Biologic therapy, Gut microbiota, DNA methylation, Cytokines, Faecal calprotectin, iomarkers
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infliximab | Adults with UC on maintenance IV infliximab. Standard-care maintenance intravenous therapy; not assigned or altered by the study. | |
| Vedolizumab | Adults with UC on maintenance IV vedolizumab. Standard-care maintenance intravenous therapy; not assigned or altered by the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faecal VOC discrimination of therapeutic versus sub-therapeutic biologic trough concentration
Cross-validated AUROC (95% CI) of the pre-specified machine-learning framework. Sensitivity, specificity, PPV and NPV also reported.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (6)
Urinary VOC discrimination of therapeutic versus sub-therapeutic trough concentration (cross-validated AUROC, 95% CI)
Measured: From enrollment to the end of treatment at 8 weeks
Change in cross-validated AUROC when VOC features are added to models containing FCP, CRP and cytokines
Measured: From enrollment to the end of treatment at 8 weeks
Association between faecal VOC features and microbiota composition and diversity (FDR-adjusted)
Measured: From enrollment to the end of treatment at 8 weeks
Association between faecal VOC features and blood DNA methylation, including interaction with remission/relapse status (FDR-adjusted
Measured: From enrollment to the end of treatment at 8 weeks
Faecal VOC discrimination of remission versus relapse (cross-validated AUROC, 95% CI)
Measured: From enrollment to the end of treatment at 8 weeks
Difference in cross-validated AUROC between faecal and urinary VOC models (paired DeLong test)
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start18 Nov 2026 (estimated)
- Primary completion8 Sep 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warwick, United Arab Emirates University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920367
- Sponsor's protocol ID
- RA664926
- Other IDs
- 26/WA/0201, 372037
- Acronym
- VIBRANT
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Data are owned by the study sponsor (University Hospitals Coventry and Warwickshire NHS Trust) and participant consent does not cover sharing of individual-level data. Summary results will be posted on ClinicalTrials.gov and published in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07920367
- Acronym / sponsor ID
- VIBRANT / RA664926
- Conditions
- Ulcerative Colitis
- Keywords
- Volatile organic compounds, Therapeutic drug monitoring, Biologic therapy, Gut microbiota, DNA methylation, Cytokines, Faecal calprotectin, iomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Collaborators
- University of Warwick, United Arab Emirates University
- Study start
- 18 Nov 2026 (estimated)
- Primary completion
- 8 Sep 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design: Single-centre, prospective, longitudinal observational cohort study at University Hospitals Coventry and Warwickshire NHS Trust (UHCW), UK. No intervention is assigned; participants continue standard-care maintenance intravenous biologic therapy.
Population: Adults (≥18 years) with ulcerative colitis (UC), confirmed by clinical, endoscopic and histological criteria per ECCO guidelines, established on maintenance intravenous infliximab or vedolizumab and attending the UHCW medical day unit. Patients in the induction phase are not eligible. Target enrolment is 99 participants.
Procedures: Participants are assessed at four consecutive routine infusion visits (every 4, 6 or 8 weeks; follow-up 12-24 weeks). At each visit, pre-infusion blood is taken for biologic trough concentration, anti-drug antibodies, C-reactive protein (CRP), full blood count, cytokines (IL-6, IL-10, IL-23) and DNA methylation. Stool and urine are collected at home before the visit. Stool is used for faecal calprotectin (FCP), VOC analysis and whole-genome shotgun metagenomic sequencing; urine is used for VOC analysis. Research samples are stored at -80 °C at the Arden Tissue Bank, UHCW, and VOC analysis is performed at the University of Warwick.
Classification: Trough concentrations are classified as sub-therapeutic at ≤1 µg/mL for infliximab and <12.7 µg/mL for vedolizumab, according to the reporting laboratories' thresholds, fixed before any VOC analysis. Remission is defined as FCP <250 µg/g and CRP ≤10 mg/L; relapse as FCP ≥250 µg/g and/or CRP >10 mg/L, or corticosteroid rescue, biologic dose escalation, or hospitalisation for UC flare (STRIDE-II).
Analysis: The primary analysis uses one baseline sample per participant. A pre-specified set of supervised machine-learning classifiers will be evaluated using nested cross-validation stratified by trough status and biologic agent, with feature selection and tuning confined to training folds. The primary outcome is cross-validated AUROC (95% CI); the hypothesis is supported if the lower 95% CI bound exceeds 0.5, with AUROC ≥0.70 considered acceptable. The urinary VOC analysis is tested in fixed sequence after the primary analysis. False discovery rate correction is applied to multi-VOC association analyses. Repeated-visit analyses use participant-grouped cross-validation.
Sample size: 77 participants (23 sub-therapeutic, 54 therapeutic) provide 80% power at two-sided α=0.05 to detect AUROC 0.70 versus 0.50 (Hanley-McNeil), assuming 30% sub-therapeutic. Allowing 20% attrition, 99 participants will be recruited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infliximab | – | –Adults with UC on maintenance IV infliximab. Standard-care maintenance intravenous therapy; not assigned or altered by the study. |
| Vedolizumab | – | –Adults with UC on maintenance IV vedolizumab. Standard-care maintenance intravenous therapy; not assigned or altered by the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (aged 18 years or older) with ulcerative colitis, confirmed by clinical, endoscopic and histological criteria, who are established on maintenance intravenous biologic therapy (infliximab or vedolizumab) and attend the medical day unit at University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK, for routine infusions. Eligible patients are identified by weekly screening of day unit infusion lists.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy or lactation
- Antibiotic use within the preceding 4 weeks
- Active malignancy
- Concomitant cytotoxic chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Faecal VOC discrimination of therapeutic versus sub-therapeutic biologic trough concentration
Time frame: From enrollment to the end of treatment at 8 weeks
Cross-validated AUROC (95% CI) of the pre-specified machine-learning framework. Sensitivity, specificity, PPV and NPV also reported.
6 secondary outcomes
Urinary VOC discrimination of therapeutic versus sub-therapeutic trough concentration (cross-validated AUROC, 95% CI)
Time frame: From enrollment to the end of treatment at 8 weeks
Change in cross-validated AUROC when VOC features are added to models containing FCP, CRP and cytokines
Time frame: From enrollment to the end of treatment at 8 weeks
Association between faecal VOC features and microbiota composition and diversity (FDR-adjusted)
Time frame: From enrollment to the end of treatment at 8 weeks
Association between faecal VOC features and blood DNA methylation, including interaction with remission/relapse status (FDR-adjusted
Time frame: From enrollment to the end of treatment at 8 weeks
Faecal VOC discrimination of remission versus relapse (cross-validated AUROC, 95% CI)
Time frame: From enrollment to the end of treatment at 8 weeks
Difference in cross-validated AUROC between faecal and urinary VOC models (paired DeLong test)
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Data are owned by the study sponsor (University Hospitals Coventry and Warwickshire NHS Trust) and participant consent does not cover sharing of individual-level data. Summary results will be posted on ClinicalTrials.gov and published in peer-reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramesh Arasaradnam, FRCP, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arif Atique, MBBS, MRCP. (+4407597729898, arif.atique@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faecal VOC discrimination of therapeutic versus sub-therapeutic biologic trough concentration (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.