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Gut bacteria cocktail aims to tame ulcerative colitis

NCT ID NCT07296315

Disease control Sponsor: MRM Health NV Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 6 times

Summary

This study tests a new medicine called MH002, which contains live bacteria meant to restore gut health in people with mild-to-moderate ulcerative colitis. About 204 adults whose current treatment isn't working well enough will receive either a low dose, high dose, or placebo capsule daily for 12 weeks. The main goal is to see if MH002 can reduce gut inflammation and improve symptoms.

What this could mean

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

Active substance
MH002 (a live bacterial product made from 6 natural gut bacteria strains)
What this could lead to
If successful, this could provide a new treatment option for people with mild-to-moderate ulcerative colitis that is not well controlled by current medications.
What could go wrong
This is a Phase 2 trial with only 204 participants, so results are still early. The treatment may not work better than placebo, and long-term safety is not yet established.

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

About 204 people

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

Started

Apr 2026

Expected to finish

May 2028

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

16 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: * Documented diagnosis (histologic diagnosis and either endoscopic or radiographic diagnosis) of ulcerative colitis (UC) at least 3 months prior to Screening. * Diagnosis of active mild-to-moderate UC at Screening as defined by an mMS of 4 to 7, including a MES ≥2 (confirmed by central reading), a Mayo Rectal Bleeding score of 1 or 2, and a Mayo Stool Frequency score ≥1. * UC lesions extending ≥10 cm from the anal verge. * Participant must either receive a stable dose of orally administered 5-aminosalicylic acid (5-ASA); have failed, due to insufficient efficacy, oral 5-ASA; have a documented intolerance or poor tolerance to an aminosalicylic acid treatment, including 5-ASA, or be contra-indicated to receive 5-ASA treatment per local labeling. * Participant must provide written informed consent or assent (parent or legal guardian must provide consent for a participant \<18 years of age who has assented to participate in the study, or as required per local regulations). * In countries not allowing females of childbearing potential (FOCBP) to participate without an acceptable contraceptive method, the FOCBP must agree to abide to local requirements and eg, use at least an acceptable method of contraception until the end of treatment. Exclusion Criteria: * Diagnosis of Crohn's disease, undetermined colitis, ischemic colitis, fulminant colitis, or toxic megacolon. * Evidence of a clinically significant, active infection of the gastrointestinal tract. * Severe UC (mMS\>7), meeting modified Truelove Witts' criteria and/or RB score of 3, participant with ulcerative proctitis only, or participant in whom colitis is most severe in the transverse colon or ascending colon, or if any hospitalization is planned at the time of Screening. * Total colectomy, stoma, or ileo-anal pouch, or history of extensive colonic resection leaving less than 30 cm of colon. * Presence of intra-abdominal fistula, abscesses, diverticulitis, or gastrointestinal bleeding unrelated to UC. * History of colon carcinoma or high-grade dysplasia. * Previous use of any advanced UC treatment, including any anti-TNF (eg, infliximab), antiintegrin (eg, vedolizumab) or anti-IL-12/23 (eg, ustekinumab) agent, anti-IL23 (eg, risankizumab), Janus kinase inhibitors (eg, tofacitinib), and sphingosine-1-phosphate receptor modulators (eg, etrasimod). * Use of sulfasalazine ≤4 weeks prior to randomization. * Use of corticosteroids or any disease-modifying antirheumatic drugs (DMARD), including thiopurines, ≤6 weeks prior to randomization into the study, except for a stable, low dose of oral corticosteroids (≤10 mg prednisolone/day) for at least 2 weeks prior to Screening colonoscopy and up to at least the Week 12 visit. * Use of antibiotics (except for local use), prebiotics, or probiotics ≤4 weeks prior to randomization or anticipated during study participation, or concomitant, chronic use of an antidiarrheal drug, or concomitant use of any rectal treatment. * Use of fecal microbiota transplantation (FMT) ≤52 weeks prior to randomization. * Treatment with another investigational drug or intervention within 30 days prior to Screening, or within 5 times the elimination half-life of the investigational drug (whichever is longest). * Any immunocompromised state, including conditions linked to severe immunosuppression (eg, active human immunodeficiency virus, malignancies, liver cirrhosis, systemic chemotherapy). * Leukopenia (total white blood cell count \<3000/μL) and/or neutropenia (absolute neutrophil count \<1000/μL), anemia (hemoglobin \<10.0 g/dL), thrombocytopenia (peripheral blood platelet count \<100 × 10\^9/L), and/or any coagulation disorder with significantly increased risk of bleeding. * Ongoing or recent (\<3 months) renal disease or insufficiency as manifested, eg, by medical history and/or clinical examination and/or (calculated or measured) glomerular filtration rate ≤60 mL/min. * Ongoing or recent (\<3 months) advanced hepatic dysfunction defined as a Child Pugh score ≥10 (Class C), or increase ≥2 times the upper limit of normal in aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT) or international normalised ratio (INR). * Clinically significant bone marrow disease if progressive or not controlled, or any history of solid organ or bone marrow transplantation. * Active intravenous drug abuse or alcohol abuse disorder as assessed by the Investigator. * Pregnancy or lactation at study entry. Note: Participants who become pregnant or start to breastfeed during the study may continue the study per the Investigator's discretion. * Participants who are inappropriate for the study per the Investigator's discretion. * An employee (or a relative of) of the Investigator, study center, contract research organization, or Sponsor.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colitis ulcerative

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    25 sites in 4 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • "Sfanta Treime" Municipal Clinical Hospital

    RECRUITING

    Chisinau, MD2068, Moldova

  • ARA Professionals

    RECRUITING

    Miami, Florida, 33155, United States

  • American Hospital Network LLC

    RECRUITING

    Tbilisi, 0102, Georgia

  • Aversi Clinic LLC

    RECRUITING

    Tbilisi, 0160, Georgia

  • Communal Non-Profit Enterprise "Regional Clinical Hospital of Ivano-Frankivsk Regional Council"

    RECRUITING

    Ivano-Frankivsk, 76008, Ukraine

  • Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"

    RECRUITING

    Lviv, 79010, Ukraine

  • Cross Creek Medical Clinic

    RECRUITING

    Fayetteville, North Carolina, 28304, United States

  • JSC Georgian Clinics

    RECRUITING

    Kutaisi, 4600, Georgia

  • K. Eristavi National Center of Experimental and Clinical Surgery JSC

    RECRUITING

    Tbilisi, 0159, Georgia

  • LEPL The First University Clinic of Tbilisi State Medical University

    RECRUITING

    Tbilisi, 0178, Georgia

  • LLC The First Medical Center

    RECRUITING

    Tbilisi, 0180, Georgia

  • LTD Institute of Clinical Cardiology

    RECRUITING

    Tbilisi, 0159, Georgia

  • LTD Krol Medical Corporation

    RECRUITING

    Tbilisi, 0180, Georgia

  • Limited Liability Company "Center of Family Medicine Plus"

    RECRUITING

    Kyiv, 04210, Ukraine

  • Limited Liability Company "Medical Centre "Consilium Medical"

    RECRUITING

    Kyiv, 04050, Ukraine

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC

    RECRUITING

    Tbilisi, 0180, Georgia

  • Medical Center "Artes Medicum" LLC

    RECRUITING

    Kyiv, 02002, Ukraine

  • Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research"

    RECRUITING

    Kyiv, 02091, Ukraine

  • Orlando Gastroenterology, P.A.

    RECRUITING

    Orlando, Florida, 32835, United States

  • PMSI "Timofei Mosneaga" Republican Clinical Hospital

    RECRUITING

    Chisinau, MD-2025, Moldova

  • PMSI "Timofei Mosneaga" Republican Clinical Hospital

    RECRUITING

    Chisinau, MD2025, Moldova

  • Peters Medical Research

    RECRUITING

    High Point, North Carolina, 27260, United States

  • Sf. Arhanghel Mihail" Municipal Clinical Hospital

    RECRUITING

    Chisinau, 2005, Moldova

  • Southern Star Research Institute

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Tropical Clinical Trials

    RECRUITING

    Palmetto Bay, Florida, 33176, United States

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