Ulcerative ColitisPhase 2Mini-MARVELNCT05539625

Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis

A Phase 2 study testing MitoQ in people with Ulcerative Colitis, run by University of Edinburgh at 1 site in United Kingdom.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Ulcerative Colitis
What is being tested?: MitoQ
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Sep 2025to 31 Oct 2026
Phase: Phase 2
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 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Age 6 to17 years in a PIBD service
Able and willing to give informed consent if aged 16-17 years of age; parents or guardian able and willing to give informed consent if a child of age 15 years and under
Confirmed UC as documented in the medical notes
Mild-moderate severity (PUCAI score 10-55)
(i) If Incident (newly diagnosed) case (biopsy confirmation of suspected UC at endoscopy) or within 2 weeks of diagnosis - no anti-inflammatory medication or if started on 5-ASA on day of endoscopy for presumed UC (ii) If Prevalent case - No medication or stable dose of existing medicine (oral/topical 5-ASA for >2 weeks at screening; thiopurine for >4 weeks at screening)

Who cannot join

Inability to swallow capsules
Young person (16-17 years of age) with inability to provide consent due to a lack of capacity
Crohn's disease (CD) or IBD unclassified (IBDU) as documented in the medical notes
Evidence of acute severe UC (ASUC) - ASUC is a medical emergency in children and young people with UC who are clinically unwell with marked diarrhoea, haematochezia and abdominal pain, and by definition have a paediatric UC activity index (PUCAI) score of at least 65 points
Physician judgement that the subject is likely to require hospitalisation for medical care or surgical intervention of any kind for UC (e.g. colectomy) within 12 weeks of baseline
Evidence of current (or previous in last 12 months) toxic megacolon (using defined paediatric criteria - radiographic evidence of transverse colon diameter ≥56 mm (or >40mm in those <10 years) PLUS evidence of systemic toxicity (such as: fever >38 degrees Celsius, tachycardia (heart rate >2 SD above mean for age), dehydration, electrolyte disturbance (sodium, potassium or chloride), altered level of consciousness, coma, hypotension or shock) or bowel perforation

Show all 21Show fewer

Infective colitis in UC (C\&S, C. difficile toxin positive or virology at screening)
Proctitis (inflammation confined to the rectum, with no proximal extension to the sigmoid) for incident cases after colonoscopy or prevalent cases at most recent colonoscopy
UC with Primary Sclerosing Cholangitis (PSC) - PSC is a chronic disease characterized by inflammation and scarring of the bile ducts resulting in strictures of the biliary tree; most cases in children are associated with IBD. The diagnosis is made by liver imaging with MRI/MRCP.
Age <18 years but in adult IBD service
Intravenous corticosteroids for treatment of colitis within 8 weeks of screening
Current or previous exposure to tacrolimus, cyclosporin, or mycophenolate,
Current or previous exposure to biological therapy (anti-TNF, vedolizumab or ustekinumab) and oral JAK-inhibitors (tofacitinib)
Subjects with current barriers in language or communication that in the judgement of local PI will impede the completion of the trial.
Female patient with child-bearing potential who does not wish to use a medically acceptable method of contraception throughout the treatment period and for 1 month after discontinuation of treatment. (Appropriate methods of contraception include IUD, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive pessary)
Pregnancy (current declared or positive urine pregnancy test) or attempting to become pregnant during trial period) or breastfeeding
A history of overdose, or significant active mental health problems.
Monogenic IBD (an autosomal condition with an IBD-like phenotype; most common in those with IBD diagnosed <2 years of age)
Subjects with current - or recent history of - severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic (including uncontrolled hypercholesterolemia), endocrine, pulmonary, cardiac, neurological disease
Subjects with a known allergy/contraindication to MitoQ.
Subjects currently taking any products containing Mitoquinol mesylate (Coenzyme Q10) or any products containing Coenzyme derivatives such as Coenzyme A (CoA, SCoA, CoASH). If subjects are on these products, they can enter the trial after a 7-day washout period.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

NHS Lothian
Edinburgh

Other trials in United Kingdom

About this study

Official title: Mitochondrial Antioxidant Therapy to Resolve Inflammation in Ulcerative Colitis (Mini-MARVEL): A Phase 2b Feasibility Randomised Placebo Controlled Trial of Oral MitoQ in Mild-tomoderately Active Paediatric UC

Mini-MARVEL study, children and young people with an active flare of UC requiring either the start of or an increase in existing mesalazine therapy will be given either MitoQ or placebo as a daily capsule for 24 weeks in the Mini-MARVEL M arm of the study. Those children and young people with an active flare of UC requiring the start of an oral steroid course will be given either MitoQ or placebo as a daily capsule for 24 weeks in the Mini- MARVEL S arm of the study, Further, newly diagnosed children and young people with UC can have either MitoQ or placebo as a daily capsule for 24 weeks with their newly started mesalazine therapy in the Mini-MARVEL M arm of the study, or with their newly started oral steroid course in the Mini-MARVEL S arm of the study. This trial will look at how feasible a multi-centre stratified RCT of this add-on (adjunct) therapy in paediatric UC is in the UK. An assessment after 6, 12 and 24 weeks will be carried out to find out if MitoQ will result in higher rates of improvement in the participants' symptoms, quality of life and gut lining inflammation. Furthermore, the trial will investigate if their UC will be better controlled and that they are less likely to need further steroids or more potent forms of drugs.

MitoQ has been shown to be safe in 2 large human clinical studies in Parkinson's disease and Hepatitis C, but the Mini-MARVEL study, starting alongside the adult MARVEL study, will be the first study in UC in children and young people. At low doses, MitoQ is used as a nutritional supplement that has an anti-oxidant effect. Currently, many drug treatments in UC are very strong, expensive and aimed at suppressing the immune system. Steroid courses are often needed but these have lots of adverse events in children and young people and are strongly disliked by many. If the Mini- MARVEL study provides supportive data on feasibility, including where we have to concentrate our efforts to include enough children and young people through to study end, we could design a full-scale trial to see if MitoQ can be a safe and cost-effective new treatment that works at blocking the specific inflammatory signal found in the gut lining of children and young people with UC.

Conditions: Ulcerative Colitis
Being tested: MitoQ, Placebo
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MitoQDietary supplement
MitoQ in inflammation: In the experimental setting, MitoQ has been extensively studied with clear mode of action on inflammatory mechanisms relevant to IBD:
MitoQ can limit the damage to mitochondria caused by mitochondrial ROS and thereby reducing the leak and oxidisation of mtDNA that are critical to its pro-inflammatory actions within the cell.
MitoQ reduces the inflammatory potential of mitochondrial DNA which have escaped or released from dying inflammatory cells.
MitoQ can influence how the immune cells generate their energy, diverting it away from a more inflammatory type of metabolism (glycolysis) MitoQ can induce autophagy, a cellular recycling mechanism that removes damaged mitochondria. Defective autophagy is heavily implicated in the pathogenesis of IBD.
Hence collectively, MitoQ acts upstream of several pro-inflammatory mechanisms with the net effect to promote resolution of inflammation and mucosal healing.
PlaceboOther
Placebo

Study groups in NCT05539625
Study group	Role	What they receive
MitoQ	Active comparator	Once daily dosing of two capsules for 40mg/d (or one capsule for 20mg/d if weight <30kgs) Receives: Dietary Supplement: MitoQ
Placebo	Placebo comparator	Participants will take an oral matched placebo daily Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility
Feasibility of a multi-centre placebo-controlled RCT of an add-on therapy in paediatric UC by the rate of participants recruited per centre over the 15 month recruitment period. Further feasibility parameters such as retention, , adherence and compliance, plus trial and drug acceptability will be assessed. Secondary outcome measures include clinical response and remission at Weeks 6 and 12; and remission, response, reductions in faecal calprotectin and steroid burden, quality of life, safety and tolerance) will be determined at Week 24.
Measured: 24 weeks

Secondary outcomes (22)

Clincial Response
At Weeks 6, 12 and 24 measured using the validated paediatric UC disease activity score 'PUCAI' (drop in PUCAI score >20 points or drop of <20 with absolute score <10 points)
Measured: 6, 12, 24 weeks
Clinical remission
At weeks 6, 12 and 24 (defined as a PUCAI score <10 points.
Measured: 6, 12, 24 weeks
Clinical response and remission
score of 2 or less + no subscore >1) at weeks 6, 12 and 24 on partial Mayo score (9 point score)
Measured: 6, 12, 24 weeks
Difference in mean PUCAI scores at weeks 6, 12 and 24 weeks
Measured: 6, 12, 24 weeks
Steroid-free remission rate at weeks 12 and 24
Measured: 12 and 24 weeks
Steroid-free remission rate at week 24
Measured: 24 weeks
Anti-TNF-free remission rate at week 24
Measured: 24 weeks
Rate of new start iv and/or oral steroid course by week 24
Measured: 24 weeks
Rate of new start immunomodulator (thiopurine/calcineurin inhibitor) by week 24
Measured: 24 weeks
Rate of new start of biological (anti-TNF, vedolizumab, ustekinumab) by week 24
Measured: 24 weeks
Proportions of participants with primary treatment failure with 24 week study period requiring escalation in medical treatment as below:
1. (i) Mini-MARVEL M - treatment with oral or intravenous corticosteroids (ii) Mini-MARVEL S - Re-treatment with oral or intravenous corticosteroids
2. Biologics (anti-TNF, anti-α4β7, anti-IL23 and oral Jak-inhibitors)
3. Azathioprine or 6-mercaptopurine in participants who were not on a thiopurine at baseline
4. Oral or intravenous ciclosporin OR oral tacrolimus
Measured: 24 weeks
Reduction of stool calprotectin of >50% compared to baseline or near normalization (<250ug/g) of faecal calprotectin at week 12 and 24
Measured: 12 and 24 weeks
Mucosal healing with faecal calprotectin <100ug/g at week 12 and at week 24
Measured: 12 and 24 weeks
Cumulative steroid dose baseline to week 24 (steroid burden)
Measured: 4 weeks
Quality of life (QoL) - the scores and change from baseline in the validated paediatric IBD quality-of-life score IMPACT 3 at week 12 and week 24
Measured: 12 and 24 weeks
PROM (TUMMY UC) - the scores and change from baseline in the validated TUMMY UC score at week 12 and week 24
Measured: 12 and 24 weeks
Rate and durations of UC-related hospitalizations
Measured: 24 weeks
Rate of colectomy for UC or UC-related complications
Measured: 24 weeks
Incidence and severity of adverse events/reactions and serious adverse events/reactions
Measured: 24 weeks
Drug concentration analyses and research into biomarkers (mitochondrial DNA and formylated peptides) at Baseline, Week 12 and Week 24, plus pharmacogenomics (via DNA sample at Baseline)
Measured: 12 and 24 weeks
Precision of the between group effect size (d) - this will be measured by the 95% confidence intervals (CI) around d.
Measured: 24 weeks
Achievement of clinically meaningful effect with add-on therapy - we will evaluate if we can gain an estimate of size of clinically meaningful effect between MitoQ and placebo as add-on therapy
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202531 Oct 2026

First posted14 Sep 2022
Study start1 Sep 2025 (estimated)
Primary completion31 Oct 2026 (estimated)
Study completion31 Oct 2026 (estimated)

Why it stopped: Unable to secure IMP supply.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05539625
Sponsor's protocol ID: AC21067
Acronym: Mini-MARVEL
Status last verified: Jan 2026
First submitted: 4 Aug 2022
Last updated: 9 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Krammel 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mitochondrial Antioxidant Therapy to Resolve Inflammation in Ulcerative Colitis (Mini-MARVEL): A Phase 2b Feasibility Randomised Placebo Controlled Trial of Oral MitoQ in Mild-tomoderately Active Paediatric UC
ClinicalTrials.gov ID: NCT05539625
Acronym / sponsor ID: Mini-MARVEL / AC21067
Conditions: Ulcerative Colitis
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Unable to secure IMP supply.
Enrolment: 0 participants (actual)
Lead sponsor: University of EdinburghUniversity, hospital or other
Collaborators: The Jon Moulton Charity Trust, MitoQ
Study start: 1 Sep 2025 (estimated)
Primary completion: 31 Oct 2026 (estimated)
Study completion: 31 Oct 2026 (estimated)
First posted: 14 Sep 2022 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
MitoQ	Active comparator	Dietary Supplement: MitoQOnce daily dosing of two capsules for 40mg/d (or one capsule for 20mg/d if weight <30kgs)
Placebo	Placebo comparator	Other: PlaceboParticipants will take an oral matched placebo daily

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Age 6 to17 years in a PIBD service
Able and willing to give informed consent if aged 16-17 years of age; parents or guardian able and willing to give informed consent if a child of age 15 years and under
Confirmed UC as documented in the medical notes
Mild-moderate severity (PUCAI score 10-55)
(i) If Incident (newly diagnosed) case (biopsy confirmation of suspected UC at endoscopy) or within 2 weeks of diagnosis - no anti-inflammatory medication or if started on 5-ASA on day of endoscopy for presumed UC (ii) If Prevalent case - No medication or stable dose of existing medicine (oral/topical 5-ASA for >2 weeks at screening; thiopurine for >4 weeks at screening)

Key exclusion criteria (21 listed)

Inability to swallow capsules
Young person (16-17 years of age) with inability to provide consent due to a lack of capacity
Crohn's disease (CD) or IBD unclassified (IBDU) as documented in the medical notes
Evidence of acute severe UC (ASUC) - ASUC is a medical emergency in children and young people with UC who are clinically unwell with marked diarrhoea, haematochezia and abdominal pain, and by definition have a paediatric UC activity index (PUCAI) score of at least 65 points
Physician judgement that the subject is likely to require hospitalisation for medical care or surgical intervention of any kind for UC (e.g. colectomy) within 12 weeks of baseline

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MitoQMitoQ in inflammation: In the experimental setting, MitoQ has been extensively studied with clear mode of action on inflammatory mechanisms relevant to IBD: MitoQ can limit the damage to mitochondria caused by mitochondrial ROS and thereby reducing the leak and oxidisation of mtDNA that are critical to its pro-inflammatory actions within the cell. MitoQ reduces the inflammatory potential of mitochondrial DNA which have escaped or released from dying inflammatory cells. MitoQ can influence how the immune cells generate their energy, diverting it away from a more inflammatory type of metabolism (glycolysis) MitoQ can induce autophagy, a cellular recycling mechanism that removes damaged mitochondria. Defective autophagy is heavily implicated in the pathogenesis of IBD. Hence collectively, MitoQ acts upstream of several pro-inflammatory mechanisms with the net effect to promote resolution of inflammation and mucosal healing.	Dietary supplement	MitoQ
PlaceboPlacebo	Other	Placebo

Primary outcome

Feasibility
Time frame: 24 weeks
Feasibility of a multi-centre placebo-controlled RCT of an add-on therapy in paediatric UC by the rate of participants recruited per centre over the 15 month recruitment period. Further feasibility parameters such as retention, , adherence and compliance, plus trial and drug acceptability will be assessed. Secondary outcome measures include clinical response and remission at Weeks 6 and 12; and remission, response, reductions in faecal calprotectin and steroid burden, quality of life, safety and tolerance) will be determined at Week 24.

22 secondary outcomes

Clincial Response
Time frame: 6, 12, 24 weeks
Clinical remission
Time frame: 6, 12, 24 weeks
Clinical response and remission
Time frame: 6, 12, 24 weeks
Difference in mean PUCAI scores at weeks 6, 12 and 24 weeks
Time frame: 6, 12, 24 weeks
Steroid-free remission rate at weeks 12 and 24
Time frame: 12 and 24 weeks
Steroid-free remission rate at week 24
Time frame: 24 weeks
Anti-TNF-free remission rate at week 24
Time frame: 24 weeks
Rate of new start iv and/or oral steroid course by week 24
Time frame: 24 weeks
Rate of new start immunomodulator (thiopurine/calcineurin inhibitor) by week 24
Time frame: 24 weeks
Rate of new start of biological (anti-TNF, vedolizumab, ustekinumab) by week 24
Time frame: 24 weeks
Proportions of participants with primary treatment failure with 24 week study period requiring escalation in medical treatment as below:
Time frame: 24 weeks
Reduction of stool calprotectin of >50% compared to baseline or near normalization (<250ug/g) of faecal calprotectin at week 12 and 24
Time frame: 12 and 24 weeks
Mucosal healing with faecal calprotectin <100ug/g at week 12 and at week 24
Time frame: 12 and 24 weeks
Cumulative steroid dose baseline to week 24 (steroid burden)
Time frame: 4 weeks
Quality of life (QoL) - the scores and change from baseline in the validated paediatric IBD quality-of-life score IMPACT 3 at week 12 and week 24
Time frame: 12 and 24 weeks
PROM (TUMMY UC) - the scores and change from baseline in the validated TUMMY UC score at week 12 and week 24
Time frame: 12 and 24 weeks
Rate and durations of UC-related hospitalizations
Time frame: 24 weeks
Rate of colectomy for UC or UC-related complications
Time frame: 24 weeks
Incidence and severity of adverse events/reactions and serious adverse events/reactions
Time frame: 24 weeks
Drug concentration analyses and research into biomarkers (mitochondrial DNA and formylated peptides) at Baseline, Week 12 and Week 24, plus pharmacogenomics (via DNA sample at Baseline)
Time frame: 12 and 24 weeks
Precision of the between group effect size (d) - this will be measured by the 95% confidence intervals (CI) around d.
Time frame: 24 weeks
Achievement of clinically meaningful effect with add-on therapy - we will evaluate if we can gain an estimate of size of clinically meaningful effect between MitoQ and placebo as add-on therapy
Time frame: 24 weeks

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 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: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MitoQ in people with Ulcerative Colitis, run by University of Edinburgh 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 5 inclusion and 21 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: withdrawn, as of the sponsor's last update on 9 Jan 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (time frame: 24 weeks). 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 NCT05539625, which also lists 1 linked publication.

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 9 Jan 2026.