Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Edinburgh
With
JP Moulton Charitable Foundation
MitoQ
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | MARVEL: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis
