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Could a mitochondrial booster calm ulcerative colitis without heavy immune drugs?

NCT ID NCT04276740

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

79 people

The number who actually took part.

Started

May 2022

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • NHS Lothian

    Edinburgh, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.