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

This is an interventional treatment trial for Ulcerative Colitis Flare Read More

Inclusion Criteria: • Active UC (Mayo of score 6 or greater with endoscopy subscore of 2 or more); or Partial Mayo Score 4-9 (e.g. without the endoscopic score)

• 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.

Exclusion Criteria:

• Severe extensive colitis as evidenced by:

  • 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 fulminant colitis, toxic megacolon or recent history of toxic megacolon within the last 6 months; or bowel perforation.
  • Evidence of acute severe UC fulfilling Truelove and Witts Criteria (>6 bloody stools/day with evidence of any of these features: tachycardia [>90bpm], fever [>37.8C], anaemia [Hb <10.5g/dl], low albumin [<30g/l]).
• Any current or previous biologic treatment including anti-TNF therapy or anti-α4β7 therapy; and oral JAK-inhibitors
• Previous treatment for UC, except those listed in the inclusion criteria.
• 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.