Gastro-Intestinal DisorderNAZANCT06956703
NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study
An observational study of Gastro-Intestinal Disorder and Crohn Disease, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to learn about the comparisons of inflammatory markers between IBD and non-IBD (control) participants. The main question it aims to answer is: Are there differences in inflammatory markers between IBD and non-IBD (control) participants. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastro-Intestinal Disorder, Crohn Disease, Ulcerative Colitis
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Dec 2022to 31 Dec 2027
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A cohort study in patients with moderate to severely active Crohn's Disease (CD) and Ulcerative Colitis (UC) who are switching to new targeted biologic therapy (with a different mode of action) - onto either anti-TNFα therapy or vedolizumab for UC or onto anti-TNFα therapy or ustekinumab or upadacitinib for CD and undergoing routine endoscopic assessments as part of normal clinical practice. We will also recruit participants without these conditions (controls) who are due for a lower GI colonoscopy as part of the UK national bowel cancer screening programme or on any hospital/ medical/ clinical screening list or any other appropriate list with no pathology found on examination.
Who may be able to join
- 1. Provision of signed and dated, written informed consent before any study specific procedures
- AND
- 2a. Patients of at least 16 years of age with active Crohn's disease defined as: CRP > = 5 mg/L OR FCP > = 250 μg/g OR Visible ulcerations on ileocolonoscopy with a total SES-CD > = 7, or > = 4 if disease is confined to the terminal ileum OR visable active disease on cross-sectional imaging. Are switching to a new mechanism of action (MOA) onto anti-TNF therapy or ustekinumab or upadacitinib
- OR
- 2b. Patients of at least 16 years (no upper age limit) with active UC defined as: CRP > = 5 mg/L OR FCP > = 250 μg/g OR Mayo endoscopy subscore > = 2. Are switching to a new mechanism of action (MOA) onto either anti-TNFα therapy or vedolizumab
- OR
- 2c. Non-IBD participants who are attending for a lower GI colonoscopy at any participating site. On any hospital/ medical/ clinical screening list or any other appropriate list with no pathology found on examination.
Who cannot join
- Inability to give informed consent
- Any positive result from previous screening for serum hepatitis B surface antigen, hepatitis C or human immunodeficiency virus (HIV)
- An ongoing infection requiring treatment
- Clinical evidence of active COVID infection and/or evidence of active COVID determined by local standard care procedures
- Participation in a clinical study with pharmacological intervention within 3 months prior to Baseline visit.
- Current diagnosis of cancer
Show all 12Show fewer
- Having received a solid organ or stem cell transplant
- Having received a transfusion of blood, plasma, or platelets within 120 days prior to enrolment
- Confirmed pregnancy at time of enrolment
- For non-IBD participants: A prior history of IBD (CD, UC, microscopic colitis, indeterminate colitis or IBD unspecified)
- Clinical judgement by the investigator that the patient should not participate in the study
- Under 16yrs of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nadia Frowd contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Nottingham
Nottingham, Nottinghamshire, NG7 2UH
Gordon Moran Professor, gordon.moran@nottingham.ac.uk
About this study
The goal of this observational study is to learn about the comparisons of inflammatory markers between IBD and non-IBD (control) participants.
The main question it aims to answer is:
Are there differences in inflammatory markers between IBD and non-IBD (control) participants.
Read the detailed description
A cohort study in patients with moderate to severely active Crohns Disease (CD) and Ulcerative Colitis (UC) who are switching to new targeted biologic therapy (with a different mode of action) - onto either anti-TNFα therapy or vedolizumab for UC or onto anti-TNFα therapy or ustekinumab or upadacitinib for CD and undergoing routine endoscopic assessments as part of normal clinical practice.
The investigator will also recruit participants without these conditions (controls) who are due for a lower GI colonoscopy as part of the UK national bowel cancer screening programme or on any hospital/ medical/ clinical screening list or any other appropriate list with no pathology found on examination.
CD \& UC patients will provide blood and stool samples at 3 timepoints (baseline, 3mths, 12mths) as well as extra tissue biopsies taken at standard care endoscopies within 12mths. Controls will provide a blood sample and stool sample as well as extra tissue biopsies taken at standard care colonoscopies.
Samples will be analysed to characterise any observable traits (phenotype) and molecular variability in patients which may be associated with clinical response to the treatment.
The investigator hopes the information gained from this study may help improve the understanding of Inflammatory Bowel Diseases (IBD) and help to develop better ways of treating the condition and predicting the course of the disease and how patients may respond to different treatments.
- Conditions
- Gastro-Intestinal Disorder, Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
- Medical subject headings
- Digestive System Diseases, Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
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 |
|---|---|---|
| Crohn's Disease - anti-TNFα therapy | Consultant will prescribe biologic dose, frequency and duration as normal standard of care | |
| Crohn's Disease - ustekinumab | Consultant will prescribe biologic dose, frequency and duration as normal standard of care | |
| Crohn's Disease - upadacitinib | Consultant will prescribe biologic dose, frequency and duration as normal standard of care | |
| Ulcerative Colitis - anti-TNFα therapy | Consultant will prescribe biologic dose, frequency and duration as normal standard of care | |
| Ulcerative Colitis - vedolizumab | Consultant will prescribe biologic dose, frequency and duration as normal standard of care | |
| Control non-IBD | No biologic will be prescribed |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of the IL-23/Th17 inflammatory axis between IBD and healthy control samples
Measured: Baseline, Month 3 and Month 12
Secondary outcomes (2)
Characterisation of IL-23/Th17 inflammatory axis within IBD biosamples stratified by prior biologic exposure
Measured: Baseline, Month 3 and Month 12
Comparison of mRNA sequencing readouts, characterisation of tissue and immune cell populations, characterisation of protein expression and characterisation of microbial species in the stool and tissue
The above will be stratified by disease type and status, demographic features of the participant, biologic exposure, clinical and endoscopic response to treatment
Measured: Baseline, Month 3 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start12 Dec 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-Intestinal DisorderStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Gordon Moran Professor, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956703
- Sponsor's protocol ID
- 22GA031
- Acronym
- NAZA
- Status last verified
- Jun 2026
- First submitted
- 24 Apr 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study
- ClinicalTrials.gov ID
- NCT06956703
- Acronym / sponsor ID
- NAZA / 22GA031
- Conditions
- Gastro-Intestinal Disorder, Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 May 2025 (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.
The goal of this observational study is to learn about the comparisons of inflammatory markers between IBD and non-IBD (control) participants.
The main question it aims to answer is:
Are there differences in inflammatory markers between IBD and non-IBD (control) participants.
Detailed description
A cohort study in patients with moderate to severely active Crohns Disease (CD) and Ulcerative Colitis (UC) who are switching to new targeted biologic therapy (with a different mode of action) - onto either anti-TNFα therapy or vedolizumab for UC or onto anti-TNFα therapy or ustekinumab or upadacitinib for CD and undergoing routine endoscopic assessments as part of normal clinical practice.
The investigator will also recruit participants without these conditions (controls) who are due for a lower GI colonoscopy as part of the UK national bowel cancer screening programme or on any hospital/ medical/ clinical screening list or any other appropriate list with no pathology found on examination.
CD \& UC patients will provide blood and stool samples at 3 timepoints (baseline, 3mths, 12mths) as well as extra tissue biopsies taken at standard care endoscopies within 12mths. Controls will provide a blood sample and stool sample as well as extra tissue biopsies taken at standard care colonoscopies.
Samples will be analysed to characterise any observable traits (phenotype) and molecular variability in patients which may be associated with clinical response to the treatment.
The investigator hopes the information gained from this study may help improve the understanding of Inflammatory Bowel Diseases (IBD) and help to develop better ways of treating the condition and predicting the course of the disease and how patients may respond to different treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Crohn's Disease - anti-TNFα therapy | – | –Consultant will prescribe biologic dose, frequency and duration as normal standard of care |
| Crohn's Disease - ustekinumab | – | –Consultant will prescribe biologic dose, frequency and duration as normal standard of care |
| Crohn's Disease - upadacitinib | – | –Consultant will prescribe biologic dose, frequency and duration as normal standard of care |
| Ulcerative Colitis - anti-TNFα therapy | – | –Consultant will prescribe biologic dose, frequency and duration as normal standard of care |
| Ulcerative Colitis - vedolizumab | – | –Consultant will prescribe biologic dose, frequency and duration as normal standard of care |
| Control non-IBD | – | –No biologic will be prescribed |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A cohort study in patients with moderate to severely active Crohn's Disease (CD) and Ulcerative Colitis (UC) who are switching to new targeted biologic therapy (with a different mode of action) - onto either anti-TNFα therapy or vedolizumab for UC or onto anti-TNFα therapy or ustekinumab or upadacitinib for CD and undergoing routine endoscopic assessments as part of normal clinical practice. We will also recruit participants without these conditions (controls) who are due for a lower GI colonoscopy as part of the UK national bowel cancer screening programme or on any hospital/ medical/ clinical screening list or any other appropriate list with no pathology found on examination.
Key inclusion criteria (7 listed)
- 1. Provision of signed and dated, written informed consent before any study specific procedures
- AND
- 2a. Patients of at least 16 years of age with active Crohn's disease defined as: CRP > = 5 mg/L OR FCP > = 250 μg/g OR Visible ulcerations on ileocolonoscopy with a total SES-CD > = 7, or > = 4 if disease is confined to the terminal ileum OR visable active disease on cross-sectional imaging. Are switching to a new mechanism of action (MOA) onto anti-TNF therapy or ustekinumab or upadacitinib
- OR
- 2b. Patients of at least 16 years (no upper age limit) with active UC defined as: CRP > = 5 mg/L OR FCP > = 250 μg/g OR Mayo endoscopy subscore > = 2. Are switching to a new mechanism of action (MOA) onto either anti-TNFα therapy or vedolizumab
Key exclusion criteria (12 listed)
- Inability to give informed consent
- Any positive result from previous screening for serum hepatitis B surface antigen, hepatitis C or human immunodeficiency virus (HIV)
- An ongoing infection requiring treatment
- Clinical evidence of active COVID infection and/or evidence of active COVID determined by local standard care procedures
- Participation in a clinical study with pharmacological intervention within 3 months prior to Baseline visit.
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
The comparison of the IL-23/Th17 inflammatory axis between IBD and healthy control samples
Time frame: Baseline, Month 3 and Month 12
2 secondary outcomes
Characterisation of IL-23/Th17 inflammatory axis within IBD biosamples stratified by prior biologic exposure
Time frame: Baseline, Month 3 and Month 12
Comparison of mRNA sequencing readouts, characterisation of tissue and immune cell populations, characterisation of protein expression and characterisation of microbial species in the stool and tissue
Time frame: Baseline, Month 3 and Month 12
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 8 Jul 2026.
Related trials for Gastro-Intestinal Disorder
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Nadia Frowd contact
Gordon Moran Professor principal investigator
University of Nottingham
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 Gastro-Intestinal Disorder and Crohn Disease, run by University of Nottingham 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 8 Jul 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 Gordon Moran Professor (0115 9249924 ext. 80608, Gordon.Moran@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The comparison of the IL-23/Th17 inflammatory axis between IBD and healthy control samples (time frame: Baseline, Month 3 and Month 12). 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 8 Jul 2026.