Inflammatory Bowel DiseasesMUSICNCT04760964
Mitochondrial DAMPs as Mechanistic Biomarkers of Mucosal Inflammation in Crohn's Disease and Ulcerative Colitis
An observational study of Inflammatory Bowel Diseases, run by University of Edinburgh at 3 sites in United Kingdom.
Trial summary
The MUSIC study is a multi-centre, longitudinal study set in the real world IBD clinical setting to investigate and develop a new biomarker approach that aims to inform both patients and clinicians of the current state of the affected gut lining (how inflamed or whether the bowel wall has completely healed). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 250 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 27 Jan 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All participants will have active IBD at the time of recruitment. The aim is to capture a wide spectrum of IBD patients with active disease, hence strict criteria for IBD disease severity/extent/activity is not applied. However, suitable potential participants must have active IBD based on clinical evaluation of referring clinician and any one of the below from investigations which have been carried out within 6 weeks of screening: 1. FC level of >100ug/g 2. Blood CRP >5mg/l 3. Endoscopic, radiological or histological evidence of active IBD There will be 2 main groups: 1. IBD patients with acute flare requiring medical treatment (corticosteroids, immunomodulator or biologics) 2. IBD patients on established medical treatments (biologics or immunomodulators) that require a change due to poor control of disease activity
Who may be able to join
- All patients must be able to give consent and aged 16 years old and over.
- All patients must have a diagnosis of IBD (CD or UC)
- All patients must have active IBD at the time of screening:
- Active IBD symptoms by referring clinician's judgement in addition to one of the below criteria (within 6 weeks of screening):
- FC level of >100ug/g
- Blood CRP >5mg/l
Show all 17Show fewer
- Endoscopic, radiological or histological evidence of active IBD
- All IBD patients with disease involvement that is amenable for endoscopic assessment of mucosal healing. This includes:
- CD patients with previous ileal or colonic surgical resection
- CD patients with perianal disease where ileo-colonoscopy or sigmoidoscopy are not contraindicated
- CD patients with ileal involvement only where endoscopic disease activity can be recorded
- All IBD patients will require a recent ileo-colonoscopy or flexible sigmoidoscopy within 6 weeks of recruitment that has:
- Clear documentation of endoscopic disease activity and extent (SES-CD and Rutgeert's score for CD; Mayo Score or UCEIS for UC)
- Photographs of endoscopic mucosal IBD disease activity
- If there is not a recent ileo-colonoscopy or flexible sigmoidoscopy, the participant will be asked to undergo an ileo-colonoscopy or flexible sigmoidoscopy at baseline.
- If patients have undergone an ileo-colonoscopy or flexible sigmoidoscopy within 6 weeks but with an endoscopic report that is insufficient in endoscopic disease activity data as per (5), potential participant can still be considered providing there is:
- Supporting objective evidence of IBD disease activity (FC, CRP) within 2 weeks of index ileo-colonoscopy or flexible sigmoidoscopy.
Who cannot join
- IBD patients with severe/fulminant disease at screening:
- Subjects with colitis fulfilling the Truelove and Witts' criteria (stool frequency >6/24 hours with all of the features of fever >38C, pulse rate >100 beats per minute, blood haemoglobin <105 g/l, albumin <30g/l)
- Subjects displaying evidence of toxic megacolon (transverse colon diameter >6m on plain abdominal X-ray with accompanying full radiological report). Note - abdominal X-ray will be carried out if clinically indicated by referring clinician
- Evidence of significant bowel obstruction, abdominal sepsis, abscess formation and fistula formation (bowel or perianal) as documented by referring clinician that is supported by clinical, radiological and blood laboratory investigations
- Referring clinician's judgement where surgical intervention (colectomy or resection) is deemed likely within 3 months of screening
- Evidence of intestinal dyplasia or malignancy (histologic, endoscopic or radiologic)
Show all 12Show fewer
- UC patients with limited involvement of the rectum (<15cm - proctitis)
- UC patients who have had a colectomy (total and subtotal)
- UC patients with an ileo-anal pouch
- IBD (UC, CD or IBD-U) with an intestinal stoma
- Patients where ileo-colonoscopy or flexible sigmoidoscopy are contra-indicated (e.g. significant co-morbidities e.g. cardiovascular, respiratory, cancer, renal failure; and pregnancy)
- Participants where there are limitations to language communication where there is a potential issue where information sheet cannot be reliably understood and/or the subject cannot provide full informed consent.
Trial locations and contacts
3 sites in 1 country.
Emma Ward contact
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Ninewells Hospital
Dundee
Craig Mowat, c.mowat@dundee.ac.uk
Craig Mowat
- Recruiting
Western General Hospital
Edinburgh
Gwo-Tzer Ho, G.Ho@ed.ac.uk
Gwo-Tzer Ho
- Not yet recruiting
NHS Greater Glasgow & Clyde
Glasgow
John Paul Seenan, johnpaul.seenan@ggc.scot.nhs.uk
John Paul Seenan
About this study
Official title: Mitochondrial DAMPs as Mechanistic Biomarkers of Mucosal Inflammation in Crohn's Disease and Ulcerative Colitis (MUSIC)
The MUSIC study is a multi-centre, longitudinal study set in the real world IBD clinical setting to investigate and develop a new biomarker approach that aims to inform both patients and clinicians of the current state of the affected gut lining (how inflamed or whether the bowel wall has completely healed).
This new biomarker approach will study a panel of molecular signs in IBD patients' blood, stools and biopsies that will be correlated to the current gold standard of direct gut visual examination using ileo-colonoscopy and flexible sigmoidoscopy tests (a fibre-optic examination of the lower small bowel and large bowel). Here, the state and appearances of IBD patients' gut lining will be assessed over one year in response to treatment given to them by their NHS IBD consultant.
This approach will focus on the role of damage associated molecular patterns (DAMPs), also known as 'danger signals'. DAMPs are found in our own cells and are released during tissue stress or injury. Like signals from bacteria, they can trigger inflammation. In the MUSIC study, blood, stool, saliva and gut samples obtained from participants during active IBD and in clinical remission will be used in order to understand how DAMPs contribute to the development of gut inflammation.
Read the detailed description
The hypothesis is that mitochondrial DAMPs are good mechanistic biomarkers for mucosal inflammation and healing in IBD.
Complete mucosal healing (total resolution and absence of ulcerations in the gut) is the most sought-after treatment target with the best long-term implication in prognosis.
Up to now IBD clinicians rely on (1) clinical symptoms (how patients feel, their bowel habit, presence of blood in stools), (2) clinical tests such as stool calprotectin (FC) and blood C-reactive protein (CRP) to inform both themselves and the patients, how well the drug treatment is working and importantly, whether the ulcers and inflammation seen in the gut lining have healed or not.
Current evidence shows that these approaches are not fully informative. For example, 30% of patients with significant subjective improvement in their symptoms following treatment of active CD have evidence of active inflammation in their gut lining when further assessed with an ileo-colonoscopy. Blood and stool tests to predict mucosal healing are only useful in around 60-70% and very limited, in guiding the doctors in how severely inflamed the bowel wall is during active IBD.
Direct visualisation using ileo-colonoscopy or flexible sigmoidoscopy is the most accurate approach to assess disease activity and mucosal healing in response to medical treatment. By knowing precisely, how the gut wall inflammation is responding to treatment, the clinician can accurately manage the IBD patient (by either changing the dose and type of treatment, and whether to carry on with expensive, strong medications with potentially serious side effects). However, in the real world, follow-up endoscopic tests are difficult to carry out as they are expensive and we lack the capacity to undertake these examinations within NHS.
Project Goals
The main goal for the MUSIC study is to investigate the role of mitochondrial DAMPs in the clinic as an indicator of gut inflammation and subsequent mucosal healing in response to medical treatment in IBD.
Secondly, further scientific studies will be carried out using blood, stool, saliva and gut biopsy samples to investigate how mitochondrial DAMPs (and all known biomarkers and biological data such as genetics) contribute to the abnormal development of gut inflammation in IBD.
Primary research questions:
- Do mitochondrial DAMPs predict the activity and severity of IBD-inflammation?
- Does normalisation of mitochondrial DAMPs reflect complete endoscopic mucosal healing in IBD?
- How do mitochondrial DAMPs compare to current biomarkers (FC, CRP) and clinical symptoms (HBI/Mayo Score) in assessing IBD inflammation and mucosal healing?
- Can a simple decision-making model be developed to predict mucosal healing based on mitochondrial DAMPs, together with relevant biological data such as genetics, blood transcriptomics, microbiome; and current clinical biomarkers such as calprotectin, faecal haemoglobin and blood CRP?
Secondary research questions:
- How are mitochondrial DAMPs released from cells in the IBD gut?
- What types of cells are important in mitochondrial DAMP release? There are many forms of inflammatory cells in affected IBD gut (e.g. macrophage, epithelial, neutrophils). It is possible that different cell types may contain more inflammatory DAMPs.
- Which type of mitochondrial DAMPs are important in causing inflammation? Can mitochondrial DAMPs pinpoint a specific underlying genetic susceptibility (e.g. autophagy) or inflammatory mechanism in IBD?
Rationale
The focus is to investigate mitochondrial DAMPs' utility in two clinically relevant scenarios: (a) How severe or active is the disease? (b) How well are we treating IBD? - with endoscopic endpoints of mucosal inflammation and healing respectively. The Simple Endoscopic Score for Crohn's Disease (SES-CD) and Endoscopic Mayo Score (eMS) will be used for CD and UC respectively. Both have been validated and used widely in research and in clinical trials. By using these objective endoscopic endpoints, mtDAMPs (and in combination with current biomarkers FC and CRP) can be tested across a range of mucosal inflammation (full healing to severe).
In addition to this, it will be investigated if mitochondrial DAMPs can identify a subclinical pathogenic mechanism (e.g. [a] defective autophagy to clear damaged mitochondria; [b] de-regulated innate immune response to mitochondrial DAMPs.) These data will pave the way for future use of mitochondrial DAMP biomarkers as part of a stratified approach for new treatments targeted at mitochondrial DAMPs and their downstream inflammatory mechanisms in IBD.
Study Population
Presently within usual NHS care, all patients with active IBD, especially those to be initiated on biologic or immunomodulator treatment, are followed up where they will have documentation of disease activity (Harvey Bradshaw Index [HBI] or UC Mayo Score [MS], stool calprotectin, C-reactive protein, albumin and blood count) to assess their well-being and response to medical treatment.
With MUSIC, patients will be followed up prospectively (aligning the usual NHS clinical care above) and will receive additional endoscopic follow-up to assess mucosal healing in response to medical treatment. Thus, the MUSIC study will incorporate a prospective endoscopic evaluation of mucosal inflammation and mucosal healing into IBD clinics.
The recruitment and subsequent clinical data and sample collection will take place at 0, 3, 6, 9 and 12 months.
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Crohn's Disease, Ulcerative Colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
The role of mitochondrial DAMPs as an indicator of gut inflammation and mucosal healing
To investigate the role of mitochondrial DAMPs in the clinic as an indicator of gut inflammation and subsequent mucosal healing in response to medical treatment in IBD.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start27 Jan 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwo-Tzer Ho, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760964
- Sponsor's protocol ID
- AC19037
- Acronym
- MUSIC
- Status last verified
- Jun 2024
- First submitted
- 17 Feb 2021
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chuah CS, Hall R, Whelan RJ, Cartlidge PD, Gros B, Iglesias-Flores E, Parkash N, Boyapati RK, Ramos-Belinchon C, Ong S, Brownson EF, Campbell IAM, Mowat C, Seenan JP, MacDonald JC; MUSIC Patient-Public Involvement Group; Ho GT. Machine-learning approach to dissect the clinical heterogeneity of IBD-associated fatigue. BMJ Digit Health Ai. 2026 Feb 26;2(1):e000037. doi: 10.1136/bmjdh-2026-000037. eCollection 2026.
PubMed 42712367Krammel T, Nie J, Hacker D, Schwerd T, Aguanno D, Haller D. Therapeutic mechanisms of exclusive enteral nutrition in Crohn's disease. Semin Immunopathol. 2025 Jul 2;47(1):28. doi: 10.1007/s00281-025-01053-w.
PubMed 40603760
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial DAMPs as Mechanistic Biomarkers of Mucosal Inflammation in Crohn's Disease and Ulcerative Colitis (MUSIC)
- ClinicalTrials.gov ID
- NCT04760964
- Acronym / sponsor ID
- MUSIC / AC19037
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Crohn's Disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Feb 2021 (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 MUSIC study is a multi-centre, longitudinal study set in the real world IBD clinical setting to investigate and develop a new biomarker approach that aims to inform both patients and clinicians of the current state of the affected gut lining (how inflamed or whether the bowel wall has completely healed).
This new biomarker approach will study a panel of molecular signs in IBD patients' blood, stools and biopsies that will be correlated to the current gold standard of direct gut visual examination using ileo-colonoscopy and flexible sigmoidoscopy tests (a fibre-optic examination of the lower small bowel and large bowel). Here, the state and appearances of IBD patients' gut lining will be assessed over one year in response to treatment given to them by their NHS IBD consultant.
This approach will focus on the role of damage associated molecular patterns (DAMPs), also known as 'danger signals'. DAMPs are found in our own cells and are released during tissue stress or injury. Like signals from bacteria, they can trigger inflammation. In the MUSIC study, blood, stool, saliva and gut samples obtained from participants during active IBD and in clinical remission will be used in order to understand how DAMPs contribute to the development of gut inflammation.
Detailed description
The hypothesis is that mitochondrial DAMPs are good mechanistic biomarkers for mucosal inflammation and healing in IBD.
Complete mucosal healing (total resolution and absence of ulcerations in the gut) is the most sought-after treatment target with the best long-term implication in prognosis.
Up to now IBD clinicians rely on (1) clinical symptoms (how patients feel, their bowel habit, presence of blood in stools), (2) clinical tests such as stool calprotectin (FC) and blood C-reactive protein (CRP) to inform both themselves and the patients, how well the drug treatment is working and importantly, whether the ulcers and inflammation seen in the gut lining have healed or not.
Current evidence shows that these approaches are not fully informative. For example, 30% of patients with significant subjective improvement in their symptoms following treatment of active CD have evidence of active inflammation in their gut lining when further assessed with an ileo-colonoscopy. Blood and stool tests to predict mucosal healing are only useful in around 60-70% and very limited, in guiding the doctors in how severely inflamed the bowel wall is during active IBD.
Direct visualisation using ileo-colonoscopy or flexible sigmoidoscopy is the most accurate approach to assess disease activity and mucosal healing in response to medical treatment. By knowing precisely, how the gut wall inflammation is responding to treatment, the clinician can accurately manage the IBD patient (by either changing the dose and type of treatment, and whether to carry on with expensive, strong medications with potentially serious side effects). However, in the real world, follow-up endoscopic tests are difficult to carry out as they are expensive and we lack the capacity to undertake these examinations within NHS.
Project Goals
The main goal for the MUSIC study is to investigate the role of mitochondrial DAMPs in the clinic as an indicator of gut inflammation and subsequent mucosal healing in response to medical treatment in IBD.
Secondly, further scientific studies will be carried out using blood, stool, saliva and gut biopsy samples to investigate how mitochondrial DAMPs (and all known biomarkers and biological data such as genetics) contribute to the abnormal development of gut inflammation in IBD.
Primary research questions:
- Do mitochondrial DAMPs predict the activity and severity of IBD-inflammation?
- Does normalisation of mitochondrial DAMPs reflect complete endoscopic mucosal healing in IBD?
- How do mitochondrial DAMPs compare to current biomarkers (FC, CRP) and clinical symptoms (HBI/Mayo Score) in assessing IBD inflammation and mucosal healing?
- Can a simple decision-making model be developed to predict mucosal healing based on mitochondrial DAMPs, together with relevant biological data such as genetics, blood transcriptomics, microbiome; and current clinical biomarkers such as calprotectin, faecal haemoglobin and blood CRP?
Secondary research questions:
- How are mitochondrial DAMPs released from cells in the IBD gut?
- What types of cells are important in mitochondrial DAMP release? There are many forms of inflammatory cells in affected IBD gut (e.g. macrophage, epithelial, neutrophils). It is possible that different cell types may contain more inflammatory DAMPs.
- Which type of mitochondrial DAMPs are important in causing inflammation? Can mitochondrial DAMPs pinpoint a specific underlying genetic susceptibility (e.g. autophagy) or inflammatory mechanism in IBD?
Rationale
The focus is to investigate mitochondrial DAMPs' utility in two clinically relevant scenarios: (a) How severe or active is the disease? (b) How well are we treating IBD? - with endoscopic endpoints of mucosal inflammation and healing respectively. The Simple Endoscopic Score for Crohn's Disease (SES-CD) and Endoscopic Mayo Score (eMS) will be used for CD and UC respectively. Both have been validated and used widely in research and in clinical trials. By using these objective endoscopic endpoints, mtDAMPs (and in combination with current biomarkers FC and CRP) can be tested across a range of mucosal inflammation (full healing to severe).
In addition to this, it will be investigated if mitochondrial DAMPs can identify a subclinical pathogenic mechanism (e.g. [a] defective autophagy to clear damaged mitochondria; [b] de-regulated innate immune response to mitochondrial DAMPs.) These data will pave the way for future use of mitochondrial DAMP biomarkers as part of a stratified approach for new treatments targeted at mitochondrial DAMPs and their downstream inflammatory mechanisms in IBD.
Study Population
Presently within usual NHS care, all patients with active IBD, especially those to be initiated on biologic or immunomodulator treatment, are followed up where they will have documentation of disease activity (Harvey Bradshaw Index [HBI] or UC Mayo Score [MS], stool calprotectin, C-reactive protein, albumin and blood count) to assess their well-being and response to medical treatment.
With MUSIC, patients will be followed up prospectively (aligning the usual NHS clinical care above) and will receive additional endoscopic follow-up to assess mucosal healing in response to medical treatment. Thus, the MUSIC study will incorporate a prospective endoscopic evaluation of mucosal inflammation and mucosal healing into IBD clinics.
The recruitment and subsequent clinical data and sample collection will take place at 0, 3, 6, 9 and 12 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants will have active IBD at the time of recruitment. The aim is to capture a wide spectrum of IBD patients with active disease, hence strict criteria for IBD disease severity/extent/activity is not applied. However, suitable potential participants must have active IBD based on clinical evaluation of referring clinician and any one of the below from investigations which have been carried out within 6 weeks of screening: 1. FC level of >100ug/g 2. Blood CRP >5mg/l 3. Endoscopic, radiological or histological evidence of active IBD There will be 2 main groups: 1. IBD patients with acute flare requiring medical treatment (corticosteroids, immunomodulator or biologics) 2. IBD patients on established medical treatments (biologics or immunomodulators) that require a change due to poor control of disease activity
Key inclusion criteria (17 listed)
- All patients must be able to give consent and aged 16 years old and over.
- All patients must have a diagnosis of IBD (CD or UC)
- All patients must have active IBD at the time of screening:
- All IBD patients with disease involvement that is amenable for endoscopic assessment of mucosal healing. This includes:
- All IBD patients will require a recent ileo-colonoscopy or flexible sigmoidoscopy within 6 weeks of recruitment that has:
Key exclusion criteria (12 listed)
- IBD patients with severe/fulminant disease at screening:
- Referring clinician's judgement where surgical intervention (colectomy or resection) is deemed likely within 3 months of screening
- Evidence of intestinal dyplasia or malignancy (histologic, endoscopic or radiologic)
- UC patients with limited involvement of the rectum (<15cm - proctitis)
- UC patients who have had a colectomy (total and subtotal)
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 role of mitochondrial DAMPs as an indicator of gut inflammation and mucosal healing
Time frame: 12 months
To investigate the role of mitochondrial DAMPs in the clinic as an indicator of gut inflammation and subsequent mucosal healing in response to medical treatment in IBD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Derived from this study: PubMed 42712367Chuah CS, Hall R, Whelan RJ, Cartlidge PD, Gros B, Iglesias-Flores E, Parkash N, Boyapati RK, Ramos-Belinchon C, Ong S, Brownson EF, Campbell IAM, Mowat C, Seenan JP, MacDonald JC; MUSIC Patient-Public Involvement Group; Ho GT. Machine-learning approach to dissect the clinical heterogeneity of IBD-associated fatigue. BMJ Digit Health Ai. 2026 Feb 26;2(1):e000037. doi: 10.1136/bmjdh-2026-000037. eCollection 2026.
- Derived from this study: PubMed 40603760Krammel T, Nie J, Hacker D, Schwerd T, Aguanno D, Haller D. Therapeutic mechanisms of exclusive enteral nutrition in Crohn's disease. Semin Immunopathol. 2025 Jul 2;47(1):28. doi: 10.1007/s00281-025-01053-w.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Emma Ward contact
Gwo-Tzer Ho principal investigator
University of Edinburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by University of Edinburgh at 3 sites 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 17 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: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gwo-Tzer Ho (01312426653, G.Ho@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The role of mitochondrial DAMPs as an indicator of gut inflammation and mucosal healing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04760964, which also lists 2 linked publications.
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 18 Jun 2024.