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

NCT ID: NCT06582264

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-27
• Study Completion Date: 2026-01-31

Brief Summary

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

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vancomycin preconditioning followed by MB310

Vancomycin 125mg QID for 5 days plus 2 day wash-out prior to receiving MB310 PO (2 capsules once a day) for 12 weeks

Group Type: EXPERIMENTAL

MB310

Intervention Type: BIOLOGICAL

Live bacterial therapeutic for oral administration

Vancomycin

Intervention Type: DRUG

Antibiotic

Vancomycin preconditioning followed by Placebo

Vancomycin 125mg QID for 5 days plus 2 day wash-out prior to receiving MB310-matching placebo PO (2 capsules once a day) for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

MB310-matching placebo for oral administration

Vancomycin

Intervention Type: DRUG

Antibiotic

Interventions

MB310

Live bacterial therapeutic for oral administration

Intervention Type: BIOLOGICAL

Placebo

MB310-matching placebo for oral administration

Intervention Type: OTHER

Vancomycin

Antibiotic

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Microbiotica Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medizinische Universitaet Innsbruck

Innsbruck, , Austria

Klinikum Klagenfurt am Woerthersee

Klagenfurt, , Austria

Uniklinikum Salzburg

Salzburg, , Austria

Medizinische Universitaet Wien

Vienna, , Austria

Acibadem City Clinic, Tokuda Hospital

Sofia, , Bulgaria

Diagnostic Consulting Center Convex EOOD

Sofia, , Bulgaria

Medical Center Rusemed EOOD

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment

Stara Zagora, , Bulgaria

Diagnostic-Consulting Center

Varna, , Bulgaria

Centrum Medyczne Kermed

Bydgoszcz, , Poland

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, , Poland

Panstwowy Instytut Medyczny MSWiA - Klinika Gastroenterologi i Chorob Wewnetrznych

Warsaw, , Poland

Warsaw IBD Point

Warsaw, , Poland

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

Warsaw, , Poland

University Hospital Birmingham

Birmingham, , United Kingdom

Addenbrooke's Hospital

Cambridge, , United Kingdom

St George's Hospital

London, , United Kingdom

Royal Victoria Infirmary

Newcastle, , United Kingdom

Countries

Austria; Bulgaria; Poland; United Kingdom

Other Identifiers

2023-507376-50

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MB310-01

Identifier Type: -

Identifier Source: org_study_id