Mini-MARVEL - Mitochondrial Antioxidant therapy in Ulcerative Colitis
Research type
Research Study
Full 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-to-moderately active paediatric UC.
IRAS ID
292732
Contact name
Gwo-Tzer Ho
Contact email
Sponsor organisation
University of Edinburgh
Eudract number
2021-005010-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Ulcerative Colitis (UC) is a condition that causes inflammation and ulceration of the inner lining of the large bowel. Individuals with UC can become very unwell with disabling bloody diarrhoea, uncontrollable bowel habit and profound tiredness. In very severe cases, UC carry the risks of rupture of the inflamed bowel wall requiring an emergency operation to remove the colon.
Our earlier studies have shown that the inflamed UC gut lining releases ‘danger signals’ arising from the mitochondria. These ‘danger signals’ attract immune cells and make inflammation worse.
Mitochondria are the ‘batteries’ or ‘power stations’ that reside within, and provide energy for living cells. In the gut lining of individuals with UC, the mitochondria are more prone to damage that in turn increases the release of these danger signals.
MitoQ protects the mitochondria and reduces the effects of these danger signals. We hypothesise that MitoQ will improve UC by reducing inflammation.There are a lack of randomised controlled trials of new therapies for UC in children and young people because of the rarity of the condition and the need to run a trial in many centres.
In the Mini-MARVEL study, 120 children and young people with an active flare of UC will be given either MitoQ or placebo as a daily capsule for 24 weeks as an adjunct therapy to usual treatment. We will look at how feasible a multi-centre stratified RCT of this add-on (adjunct) therapy in paediatric UC is in the UK. We will also carry out an assessment after 6, 12 and 24 weeks to find out if MitoQ will result in higher rates of improvement in the participants’ symptoms, quality of life and gut lining inflammation. We 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.
REC name
Wales REC 5
REC reference
21/WA/0332
Date of REC Opinion
8 Dec 2021
REC opinion
Further Information Favourable Opinion