CompletedPhase 1

A Phase 1b Trial to Evaluate the Safety of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis

Austria, Bulgaria, Poland29 participantsStarted 2024-09-27

Plain-language summary

A Phase 1b study to evaluate the safety and tolerability of MB310 given to patients who have active mild-to-moderate ulcerative colitis.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 treatme…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and causality of adverse events (AEs), treatment-emergent AES, AEs of Scientific Interest and SAEs

Timeframe: From Visit 1 to End of Follow-Up (12 weeks after the last dose of study treatment)

Incidence of treatment-emergent clinically significant changes in laboratory parameters, based on haematology, clinical chemistry, and urinalysis test results

Timeframe: From Visit 1 to End of Follow-Up (12 weeks after the last dose of study treatment)

Incidence of treatment-emergent clinically significant changes in 12-lead ECG parameters, vital signs, and physical examination

Timeframe: From Visit 1 to End of Follow-Up (12 weeks after the last dose of study treatment)

Trial details

NCT IDNCT06582264

SponsorMicrobiotica Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-08

View on ClinicalTrials.gov More Ulcerative Colitis trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence and causality of adverse events (AEs), treatment-emergent AES, AEs of Scientific Interest and SAEs

Timeframe: From Visit 1 to End of Follow-Up (12 weeks after the last dose of study treatment)

Incidence of treatment-emergent clinically significant changes in laboratory parameters, based on haematology, clinical chemistry, and urinalysis test results

Timeframe: From Visit 1 to End of Follow-Up (12 weeks after the last dose of study treatment)

Incidence of treatment-emergent clinically significant changes in 12-lead ECG parameters, vital signs, and physical examination

Timeframe: From Visit 1 to End of Follow-Up (12 weeks after the last dose of study treatment)