MARVEL: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis

Inclusion Criteria

• •Baseline rectal bleeding Mayo score of 1 or more
• •≥18 years old
• •Confirmed diagnosis of UC confirmed on histology and endoscopic evidence for ≥3 months prior to screening.
• •Able to start taking prednisolone at the same time as the study drug/placebo
• •Subjects currently receiving the following treatment for UC are eligible providing they have been on stable dose for designated period of time
• •* Oral 5-ASA or sulfasalazine stable dose for at least 4 weeks prior to inclusion and during the study period.
• •* Azathioprine, 6-mercaptopurine stable dose for 8 weeks prior to study.
• •* Topical treatment (5-ASA or steroid based) for active UC flare including suppository and enema.
• •Able and willing to give informed consent.
• •UC confined to proctitis (distal 15 cm or less)
• •UC with Primary Sclerosing Cholangitis (PSC)
• •Diagnosis of Crohn's disease or indeterminate colitis
• •Pregnancy (Current or attempting to become pregnant during trial period) or breastfeeding
• •Cyclosporine, mycophenolate, or tacrolimus administration within 8 weeks of screening.
• •Intravenous corticosteroids for treatment of colitis within 8 weeks of screening
• •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 who have positive stool examinations for enteric pathogens or Clostridium difficile toxin at screening.
• •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.
• •Subjects with current barriers in language or communication that in the judgement of local PI will impede the completion of the trial.
• •A history of overdose or suicide, or significant active mental health problems.