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New gut bacteria therapy shows promise for colitis

NCT ID NCT06582264

Disease control Sponsor: Microbiotica Ltd Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study tested a new treatment called MB310 in 29 adults with mild-to-moderate ulcerative colitis. The main goal was to see if it is safe and how well it takes hold in the body. Participants received either MB310 or a placebo, and researchers monitored side effects and signs of disease control.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

29 people

The number who actually took part.

Started

Sep 2024

Finished

Jan 2026

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 70 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: The main inclusion criteria include but are not limited to the following: * Must be aged 18 to 70 years, inclusive, at the time of signing informed consent; * Must have newly diagnosed or a history of recurrent UC based on clinical, endoscopic, and histological assessments; * Must have active, mild-to-moderate UC as defined by the Modified Mayo Score (MMS) of ≥4 and ≤7, and an Endoscopic Subscore of ≤2 in the most affected area proximally ≥15 cm from anal verge; * Male patients, and female patients of childbearing potential who are at risk of pregnancy, must agree to use a highly effective method of birth control * Female patients must not be pregnant or breastfeeding; * Male patients must agree to abstain from sperm donation; * Must be able to understand and comply with the Protocol requirements; and * Must be willing and able to provide written informed consent at Screening (Visit 1). Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Disease limited to proctitis \<15 cm from anal verge; * Short bowel or malabsorption syndromes; * Prior intestinal or colon resection surgery (with exception of cholecystectomy or appendectomy); * Severe/fulminant UC; * Other forms of inflammatory bowel disease including diagnostic uncertainty by the Investigator, or functional gastrointestinal disorders; * Positive stool test for parasites, bacterial pathogens, or Clostridium difficile; * Use of any of the following treatments: * Oral 5-ASA products at a dose \>3.0 g per day (unless the use is currently stable and anticipated to remain stable during the study); * Aspirin or other nonsteroidal anti-inflammatory drugs (except aspirin for cardioprotective reasons at a dose of ≤325 mg per day); * Loperamide and other antidiarrheal agents or probiotics; * Antibiotics or other antibacterial treatment (unless an ophthalmic or otic antibiotic preparation, or a topical antibiotic for skin infection); * Faecal Matter Transplant (FMT) or administration of Vowst®, Rebiotix®, or other Live Biotherapeutic Product (LBP); * Intravenous or intramuscular corticosteroids; * Oral corticosteroids \>10 mg prednisolone or equivalent per day; * Any drugs formulated for rectal administration and/or interventions; * Immunomodulating or immunosuppressing drugs (unless the use is currently stable and anticipated to remain stable during the study); * Biologics, ozanimod, etrasimod, tofacitinib, filgotinib, or upadacitinib; or * Proton pump inhibitors (PPIs) or H2 blockers. * Patients whose disease has not responded to or lost response to 2 or more advanced therapies (biologics or small molecules); * Significant liver impairment; * Concurrent primary sclerosing cholangitis; * Clinically significant hematological function abnormalities; * Known hypersensitivity, intolerance, or contraindication to oral vancomycin, MB310, and/or any excipients; * History of, or known malignancy (unless adequately treated (i.e., cured) basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence within 5 years prior to Screening); * Any infectious disease (HIV is allowed where certain protocol-specified criteria are met); * Significant cardiovascular condition; * Involvement in another clinical study (unless observational) within 4 weeks of Screening from the last dose of study drug or 5 half-lives, whichever is longer; or * Any other clinically relevant or poorly controlled, unstable condition that would confound study endpoints or adversely affect patient safety or compliance.

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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.

Ulcerative colitis

Contacts and locations

Locations

  • Acibadem City Clinic, Tokuda Hospital

    Sofia, Bulgaria

  • Addenbrooke's Hospital

    Cambridge, United Kingdom

  • Centro Medico Teknon

    Barcelona, Spain

  • Centrum Medyczne Kermed

    Bydgoszcz, Poland

  • Corporacio Sanitaria Parc Tauli - Hospital de Sabadell

    Sabadell, Spain

  • Diagnostic Consulting Center Convex EOOD

    Sofia, Bulgaria

  • Diagnostic-Consulting Center

    Varna, Bulgaria

  • Hospital Alvaro Cunqueiro

    Vigo, Spain

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, Spain

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, Spain

  • Klinikum Klagenfurt am Woerthersee

    Klagenfurt, Austria

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, Poland

  • Medical Center Rusemed EOOD

    Sofia, Bulgaria

  • Medizinische Universitaet Innsbruck

    Innsbruck, Austria

  • Medizinische Universitaet Wien

    Vienna, Austria

  • Panstwowy Instytut Medyczny MSWiA - Klinika Gastroenterologi i Chorob Wewnetrznych

    Warsaw, Poland

  • St George's Hospital

    London, United Kingdom

  • Uniklinikum Salzburg

    Salzburg, Austria

  • University Hospital Birmingham

    Birmingham, United Kingdom

  • University Multiprofile Hospital for Active Treatment

    Stara Zagora, Bulgaria

  • Warsaw IBD Point

    Warsaw, Poland

  • Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Gastroenterologii i Chorob Wewnetrznych

    Warsaw, Poland

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