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Could a simple supplement tame gut inflammation in kids?

NCT ID NCT05539625

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aimed to test whether MitoQ, a dietary supplement with antioxidant properties, could help control inflammation in children aged 6–17 with mild-to-moderate ulcerative colitis. Participants would have taken MitoQ or a placebo daily for 24 weeks alongside their usual medication. However, the trial was withdrawn before any participants were enrolled, so no data were collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MitoQ (a dietary supplement with antioxidant effects)
What this could lead to
If this trial had succeeded, it could have pointed toward a safer, cheaper add-on treatment for children with ulcerative colitis, potentially reducing the need for steroids and stronger immune-suppressing drugs.
What could go wrong
The trial was withdrawn before enrolling any participants, so no results are available. Even if it had run, it was a small feasibility study, not designed to prove effectiveness.

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.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Oct 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

6 to 17 years

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: * 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) Exclusion Criteria: * 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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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.