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
The Jon Moulton Charity Trust
MitoQ
Age
6–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 6 to17 years in a PIBD service
Able and willing to give informed consent if aged 16-17 years of age; parents or guardian able and willing to give informed consent if a child of age 15 years and under
Confirmed UC as documented in the medical notes
Mild-moderate severity (PUCAI score 10-55)
(i) If Incident (newly diagnosed) case (biopsy confirmation of suspected UC at endoscopy) or within 2 weeks of diagnosis - no anti-inflammatory medication or if started on 5-ASA on day of endoscopy for presumed UC (ii) If Prevalent case - No medication or stable dose of existing medicine (oral/topical 5-ASA for \>2 weeks at screening; thiopurine for \>4 weeks at screening)
You may not be if
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.
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