Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis

Exclusion Criteria

• •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
• •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.