Ulcerative ColitisPhase 1COMPOSER-1NCT06582264
A Phase 1b Trial to Evaluate the Safety of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis
A Phase 1 study testing MB310 and Vancomycin in people with Ulcerative Colitis, run by Microbiotica Ltd at 22 sites in 5 countries.
Trial summary
A Phase 1b study to evaluate the safety and tolerability of MB310 given to patients who have active mild-to-moderate ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- MB310 and Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 27 Sep 2024to 8 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
Bulgaria5 sites
Acibadem City Clinic, Tokuda Hospital
Sofia
Diagnostic Consulting Center Convex EOOD
Sofia
Medical Center Rusemed EOOD
Sofia
University Multiprofile Hospital for Active Treatment
Stara Zagora
Diagnostic-Consulting Center
Varna
Poland5 sites
Centrum Medyczne Kermed
Bydgoszcz
Korczowski Bartosz, Gabinet Lekarski
Rzeszów
Panstwowy Instytut Medyczny MSWiA - Klinika Gastroenterologi i Chorob Wewnetrznych
Warsaw
Warsaw IBD Point
Warsaw
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Gastroenterologii i Chorob Wewnetrznych
Warsaw
Spain5 sites
Centro Medico Teknon
Barcelona
Hospital Universitario Juan Ramon Jimenez
Huelva
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
Sabadell
Hospital Clinico Universitario de Santiago
Santiago de Compostela
Hospital Alvaro Cunqueiro
Vigo
Austria4 sites
Medizinische Universitaet Innsbruck
Innsbruck
Klinikum Klagenfurt am Woerthersee
Klagenfurt
Uniklinikum Salzburg
Salzburg
Medizinische Universitaet Wien
Vienna
United Kingdom3 sites
University Hospital Birmingham
Birmingham
Addenbrooke's Hospital
Cambridge
St George's Hospital
London
About this study
Official title: A Phase 1b, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Safety, Engraftment, and Initial Signs of Clinical Activity of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis
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
- Being tested
- MB310, Placebo, Vancomycin
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB310Biological
Live bacterial therapeutic for oral administration
PlaceboOther
MB310-matching placebo for oral administration
VancomycinDrug
Antibiotic
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin preconditioning followed by MB310 | Experimental | Vancomycin 125mg QID for 5 days plus 2 day wash-out prior to receiving MB310 PO (2 capsules once a day) for 12 weeks Receives: Biological: MB310; Drug: Vancomycin |
| Vancomycin preconditioning followed by Placebo | Placebo comparator | 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 Receives: Other: Placebo; Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and causality of adverse events (AEs), treatment-emergent AES, AEs of Scientific Interest and SAEs
Measured: 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
Measured: 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
Measured: From Visit 1 to End of Follow-Up (12 weeks after the last dose of study treatment)
Secondary outcomes (8)
Percentage of patients achieving clinical remission at Day 91
Clinical remission defined as a Modified Mayo Score (MMS) 0 to 2 with endoscopic subscore of 0 or 1
Measured: Day 91
Percentage of patients achieving steroid-free remission at Day 91
No steroid exposure at Day 91 with a MMS score of 0 to 2 with endoscopic subscore of 0 or 1
Measured: Day 91
Percentage of patients achieving persistent steroid-free remission at Day 91
No steroid exposure between Day 64 and Day 91 with a MMS score of 0 to 2 with endoscopic subscore of 0 or 1
Measured: Day 64 to Day 91
Percentage of patients achieving clinical response at Day 91
Clinical response defined as a decrease in MMS by 2 or more points and at least a 30% reduction from baseline, and a decrease in the rectal bleeding subscore of 1 or more or an absolute rectal bleeding subscore of 0 or 1
Measured: Day 91
Percentage of patients achieving endoscopic improvement at Day 91
Endoscopic improvement is defined as a decrease in MMS endoscopic subscore by 1 or more point from baseline
Measured: Day 91
Percentage of patients who achieve clinical improvement at Day 64 (Visit 10) and Day 91 (Visit 11)
Clinical improvement defined as a decrease in Partial Mayo Score (pMayo) of 2 or more points from baseline
Measured: Day 91
Time to clinical improvement
Clinical improvement defined as a decrease in Partial Mayo Score (pMayo) of 2 or more points from baseline
Measured: End of Follow-Up (12 weeks after the last dose of study treatment)
Engraftment of MB310 bacteria into patients' intestinal microbial community
Measurement of MB310 strain colonisation in stool samples using a qPCR-based approach.
Measured: Up to End of Follow-Up (12 weeks after the last dose of study treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start27 Sep 2024
- Primary completion8 Jan 2026
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microbiotica Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582264
- Sponsor's protocol ID
- MB310-01
- Other IDs
- 2023-507376-50, 2023
- Acronym
- COMPOSER-1
- Status last verified
- Jun 2026
- First submitted
- 19 Aug 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Safety, Engraftment, and Initial Signs of Clinical Activity of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06582264
- Acronym / sponsor ID
- COMPOSER-1 / MB310-01
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Microbiotica LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1b study to evaluate the safety and tolerability of MB310 given to patients who have active mild-to-moderate ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin preconditioning followed by MB310 | Experimental | Biological: MB310, Drug: VancomycinVancomycin 125mg QID for 5 days plus 2 day wash-out prior to receiving MB310 PO (2 capsules once a day) for 12 weeks |
| Vancomycin preconditioning followed by Placebo | Placebo comparator | Other: Placebo, Drug: VancomycinVancomycin 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (29 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MB310Live bacterial therapeutic for oral administration | Biological | Vancomycin preconditioning followed by MB310 |
| PlaceboMB310-matching placebo for oral administration | Other | Vancomycin preconditioning followed by Placebo |
| VancomycinAntibiotic | Drug | Vancomycin preconditioning followed by MB310, Vancomycin preconditioning followed by Placebo |
Primary outcome
Incidence and causality of adverse events (AEs), treatment-emergent AES, AEs of Scientific Interest and SAEs
Time frame: 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
Time frame: 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
Time frame: From Visit 1 to End of Follow-Up (12 weeks after the last dose of study treatment)
8 secondary outcomes
Percentage of patients achieving clinical remission at Day 91
Time frame: Day 91
Percentage of patients achieving steroid-free remission at Day 91
Time frame: Day 91
Percentage of patients achieving persistent steroid-free remission at Day 91
Time frame: Day 64 to Day 91
Percentage of patients achieving clinical response at Day 91
Time frame: Day 91
Percentage of patients achieving endoscopic improvement at Day 91
Time frame: Day 91
Percentage of patients who achieve clinical improvement at Day 64 (Visit 10) and Day 91 (Visit 11)
Time frame: Day 91
Time to clinical improvement
Time frame: End of Follow-Up (12 weeks after the last dose of study treatment)
Engraftment of MB310 bacteria into patients' intestinal microbial community
Time frame: Up to End of Follow-Up (12 weeks after the last dose of study treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MB310 and Vancomycin in people with Ulcerative Colitis, run by Microbiotica Ltd at 22 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Bulgaria, Poland, Spain, Austria, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and causality of adverse events (AEs), treatment-emergent AES, AEs of Scientific Interest and SAEs (time frame: From Visit 1 to End of Follow-Up (12 weeks after the last dose of study treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.