Could a mitochondrial booster calm ulcerative colitis without heavy immune drugs?
NCT ID NCT04276740
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether MitoQ, a supplement that protects cell batteries (mitochondria), can help people with moderate ulcerative colitis (UC) flare-ups. About 79 adults will take either MitoQ or a placebo daily for 24 weeks, alongside standard steroid treatment. The goal is to see if MitoQ improves symptoms and gut healing, potentially offering a safer, cheaper option than strong immune-suppressing drugs.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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79 people
The number who actually took part.
- Started
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May 2022
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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NHS Lothian
Edinburgh, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.