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Could a simple food supplement tame ulcerative colitis?

NCT ID NCT07619638

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 a once-daily food supplement designed to improve gut bacteria in people with mild-to-moderate ulcerative colitis. About 162 adults will take either the supplement or a placebo for 24 weeks, alongside their usual treatment. The goal is to see if the supplement helps achieve remission, meaning no bleeding, better stool frequency, and lower inflammation markers.

What this could mean

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

Active substance
microbiome-targeted food supplement
What this could lead to
If it works, this could offer a simple, food-based option to help control ulcerative colitis symptoms and reduce gut inflammation.
What could go wrong
This is an early phase 2b trial with only 162 participants, so results may not apply to everyone. The supplement is not a cure and is meant to be used alongside standard care.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 162 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 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: 1. Adults aged 18 to 75 years inclusive at screening. 2. Documented diagnosis of ulcerative colitis established at least 3 months before screening, based on standard clinical, endoscopic, and histologic criteria. 3. Mild-to-moderate active ulcerative colitis defined by a partial Mayo score of 4 to 8 at screening. 4. Rectal bleeding subscore of at least 1 at screening. 5. Objective intestinal inflammation defined by fecal calprotectin of at least 250 micrograms per gram at screening, measured by the central laboratory or by a validated harmonized assay. 6. Eligible disease extent: left-sided colitis or extensive/pancolitis. Proctosigmoiditis is eligible if inflammation extends beyond isolated proctitis and is measurable by study endoscopy. Isolated ulcerative proctitis (E1 only) is eligible only within a prespecified cap not exceeding 10 percent of total enrollment. 7. Either no current ulcerative colitis-directed therapy, or stable oral and/or rectal 5-aminosalicylate (5-ASA, mesalamine) therapy at unchanged dose for at least 8 weeks before randomization, with intent to continue at the same unchanged dose through Week 24 unless rescue therapy is clinically required. 8. Able and willing to provide written informed consent. 9. Able and willing to comply with study visits, stool sampling, endoscopy, medication restrictions, and diary/patient-reported outcome completion. 10. Participants of childbearing potential must agree to use a highly effective method of contraception during dosing and for at least 4 weeks after the last dose, in accordance with EMA/CTFG guidance and local ethics requirements. Exclusion Criteria: 1. Crohn disease, inflammatory bowel disease-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or any other non-ulcerative-colitis form of colitis. 2. Severe ulcerative colitis, acute severe ulcerative colitis, fulminant colitis, toxic megacolon, or any disease severity requiring immediate hospitalization or treatment escalation in the investigator's judgment. 3. Isolated ulcerative proctitis (E1 only) outside the prespecified 10 percent enrollment cap. 4. Use of biologics, Janus kinase (JAK) inhibitors, sphingosine-1-phosphate (S1P) receptor modulators, or systemic immunosuppressants within 8 weeks before randomization, or planned use of any of these during the trial. 5. Systemic corticosteroids within 4 weeks before randomization. 6. Current budesonide-class therapy at baseline. 7. Rectal or topical corticosteroids unless discontinued at least 2 weeks before randomization. 8. Antibiotic use within 4 weeks before randomization, except topical antibiotics not expected to affect the gut microbiota. 9. Probiotic, prebiotic, synbiotic, postbiotic, fermented microbiome-directed supplement, or other non-study microbiome-directed product within 4 weeks before randomization, or planned use during the trial. 10. Active or recent Clostridioides difficile infection within 12 weeks before screening (screening uses a two-step algorithm: glutamate dehydrogenase plus toxin A/B enzyme immunoassay, with reflex nucleic acid amplification testing for discordant results). 11. Positive stool test for any clinically relevant enteric infection at screening, per local diagnostic standard operating procedures. 12. Prior colectomy, planned colectomy, known dysplasia requiring intervention, or colorectal cancer. 13. Pregnancy, breastfeeding, or planned pregnancy during the trial. 14. Uncontrolled clinically significant comorbidity, including but not limited to uncontrolled diabetes, advanced liver or renal disease, unstable cardiovascular disease, immunodeficiency, active malignancy other than adequately treated non-melanoma skin cancer, or any other condition compromising participant safety or interpretation of study results. 15. Known allergy, intolerance, or contraindication to any component of the investigational product or matching placebo. 16. Participation in another interventional clinical trial within 30 days before screening. 17. Any other condition that, in the investigator's judgment, would make participation unsafe or compromise protocol adherence.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ege University

    RECRUITING

    Izmir, Turkey (Türkiye)

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