Colitis, Ulcerative
Phase 2 Study of MH002 for Mild-to-Moderate Ulcerative Colitis
This randomized Phase 2 study is investigating the effects and safety of two daily oral doses of MH002 versus placebo in people with mild-to-moderate ulcerative colitis insufficiently controlled with 5-aminosalicylic acid.
Registry title: Confirmatory Clinical Study in Active Ulcerative Colitis
6 recruiting U.S. sites ↓Study at a glance
- Age
- 16 Years and older
- Treatment
- Low-dose MH002 or High-dose MH002
- Design
- Randomized · Quadruple
- Central study contact
- Jean-Michel Muhlinghaus, DVM+32 9 277 08 50clinicaltrials@mrmhealth.com
- Sponsor
- MRM Health NV
Research question
Do two different doses of MH002, compared with placebo, affect ulcerative colitis activity and safety outcomes in people with mild-to-moderate disease insufficiently controlled with 5-aminosalicylic acid?
Participant snapshot
Who the study is looking for
- The study is looking for people age 16 or older.
- The study is looking for people with ulcerative colitis diagnosed at least three months before screening.
- The study is looking for people whose ulcerative colitis is active and rated mild to moderate at screening using specified Mayo score measures.
- Participants must meet one of the registry's specified 5-aminosalicylic acid conditions: stable current use, insufficient effect, intolerance or poor tolerance, or a contraindication.
- Recruiting locations are listed in the United States, Georgia, and Moldova, but the study team must confirm whether a particular site is still open.
Participation overview
What participation may involve
Participants are randomly assigned to take a low-dose MH002, high-dose MH002, or placebo capsule once daily. The registry describes a 12-week induction treatment period and says long-term treatment effects will also be investigated, but does not report the full individual participation schedule. What participation may involve: - Take the assigned study capsule by mouth once daily. - Undergo endoscopic assessments used to compare the Mayo Endoscopic Subscore at baseline and Week 12. - Record stool frequency and rectal bleeding in an electronic diary for patient-reported outcome scoring. - Provide samples or undergo assessments for histology, fecal calprotectin, laboratory parameters, and vital signs. The registry explicitly describes a 12-week induction treatment period. It mentions investigating long-term treatment effects but does not state the total duration for an individual participant.
Study interventions
What participants may receive or do
- Low-dose MH002: A once-daily oral capsule containing six naturally occurring commensal bacterial strains, at a dose of 1 × 10^10 equivalent colony-forming units.
- High-dose MH002: A once-daily oral capsule containing six naturally occurring commensal bacterial strains, at a dose of 4 × 10^10 equivalent colony-forming units.
- Placebo: A blank placebo capsule taken orally once daily.
Study design
How the comparison works
This Phase 2 treatment study assigns participants to parallel groups receiving low-dose MH002, high-dose MH002, or placebo. Participants are randomly assigned to one of the three parallel study groups; the registry does not report the assignment ratios. The study uses quadruple masking: participants, care providers, investigators, and outcome assessors are masked to treatment assignment. The placebo group serves as the comparison group for the two MH002 dose groups. The placebo is described as a blank oral capsule taken once daily; the registry does not state each participant's probability of receiving it.
Reported activities
Procedures and tests
- A screening assessment must confirm active mild-to-moderate ulcerative colitis using the modified Mayo Score, including centrally read endoscopy, rectal bleeding, and stool-frequency scores.
- Endoscopic disease activity is assessed with the Mayo Endoscopic Subscore at baseline and Week 12.
- Biopsy tissue is assessed with the Robarts Histopathology Index at baseline and Week 12.
- Fecal calprotectin is measured at baseline and Week 12.
- An electronic diary records stool frequency and rectal bleeding for the two-item Patient-Reported Outcome score.
- Safety monitoring includes treatment-emergent adverse events, serious adverse events, laboratory parameters, and vital signs during the 12-week treatment period.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Ulcerative colitis must have been documented by histology plus either endoscopy or radiography at least three months before screening.
- At screening, disease must be active and mild to moderate, with a modified Mayo Score of 4 to 7, centrally confirmed Mayo Endoscopic Subscore of at least 2, rectal bleeding score of 1 or 2, and stool-frequency score of at least 1.
- Ulcerative colitis lesions must extend at least 10 centimeters from the anal verge.
- A participant must be taking a stable oral 5-aminosalicylic acid dose, have had insufficient benefit from oral 5-aminosalicylic acid, have documented intolerance or poor tolerance, or have a contraindication under local labeling.
- Participants must be age 16 or older; consent or assent requirements apply, including parent or legal-guardian consent for participants younger than 18 where required.
- Where local rules require contraception for females of childbearing potential, participants must follow those rules through the end of treatment.
Possible reasons someone may not be able to join
- People with Crohn's disease, undetermined colitis, ischemic colitis, fulminant colitis, or toxic megacolon are excluded.
- A clinically significant active gastrointestinal infection is exclusionary.
- Exclusions include severe ulcerative colitis, rectal-bleeding score of 3, ulcerative proctitis only, disease most severe in the transverse or ascending colon, or planned hospitalization at screening.
- People with a total colectomy, stoma, ileo-anal pouch, or extensive colon resection leaving less than 30 centimeters of colon are excluded.
- Previous use of any listed advanced ulcerative colitis treatment—including biologics, Janus kinase inhibitors, or sphingosine-1-phosphate receptor modulators—is exclusionary.
- Sulfasalazine use within four weeks before randomization is exclusionary.
- Corticosteroid or disease-modifying antirheumatic drug use within six weeks before randomization is generally excluded, except for a stable oral corticosteroid dose of no more than 10 mg prednisolone daily under the stated timing conditions.
- Antibiotics other than local treatments, prebiotics, or probiotics within four weeks before randomization or anticipated during participation are excluded; chronic antidiarrheal use and any rectal treatment are also excluded.
- Fecal microbiota transplantation within 52 weeks before randomization is exclusionary.
- An immunocompromised state, including the listed conditions associated with severe immunosuppression, is exclusionary.
- The specified low white-cell, neutrophil, hemoglobin, or platelet values, or a coagulation disorder with significantly increased bleeding risk, are exclusionary.
- Pregnancy or breastfeeding at study entry is exclusionary, although the registry says participants who become pregnant or begin breastfeeding during the study may continue at the investigator's discretion.
Important unknowns
What the record does not make clear
- The registry does not state how many in-person or remote visits participants have or how often visits occur.
- A 12-week induction treatment period is described, and long-term effects will be investigated, but the total duration for an individual participant is not stated.
- Three randomized groups are listed, but their assignment ratios and the probability of receiving placebo are not reported.
- The eligibility criteria address 5-aminosalicylic acid and limited corticosteroid use, but the record does not fully explain which ulcerative colitis medicines continue during the study.
- The registry does not describe what treatment is available if ulcerative colitis worsens during participation.
- The record supports screening or baseline and Week 12 endoscopic assessments but does not state the procedure type, preparation, sedation, or whether additional endoscopies occur later.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants are compensated.
- The registry does not state whether transportation, lodging, meals, or parking are reimbursed.
- The registry does not describe access to MH002 after study treatment ends.
- The overall study and listed sites are marked recruiting, but registry status does not confirm that every site currently has openings for every participant group.
Before contacting the site
Questions for the study team
- How many visits are required, when do they occur, and which visits must be completed at the study site?
- How long does participation last after the 12-week induction period, and what does the long-term phase involve?
- What is the randomization ratio and the chance of receiving placebo?
- Which current ulcerative colitis medicines may continue, and are any additional washout periods required?
- What happens if symptoms worsen, including what rescue treatment is available and when study treatment would be stopped?
- What endoscopies, biopsies, stool samples, blood tests, and electronic-diary entries are required, and how often?
- Which costs are covered, is compensation offered, and is travel support available?
- Is the nearest listed site currently screening participants, and whom should I contact there?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and how does my recent disease activity compare with the study's mild-to-moderate activity requirements?
- How could the study's medication restrictions affect my current ulcerative colitis treatment and risk of a flare?
- What approved treatment alternatives are available to me if my current 5-aminosalicylic acid treatment is not controlling the disease?
- Are there clinical concerns for me with a live biotherapeutic product containing bacterial strains, given my medical history and laboratory results?
- How should my regular gastroenterology care be coordinated with the research team if I am screened or enrolled?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
The main goal of the study is to check if MH002 works and is safe to use. In a previous study in 45 patients with Ulcerative Colitis, MH002 was found to have favorable effects. In this study, 2 different doses will be tested, and long-term treatment effects will be investigated. MH002 is a live biotherapeutic product (LBP). This is a biological medicine containing live bacteria used to restore the normal function of a gut that is damaged by ulcerative colitis (UC). Ulcerative colitis is a bowel disease that causes inflammation and sores in the gut.
Study design and administration
- Organization
- MRM Health NV
- Organization class
- Industry
- Organization study ID
- MH002-UC-202
- Lead sponsor
- MRM Health NV
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Child, Adult, Older Adult
Study arms
Experimental
Low-dose MH002
Interventions: Drug: Low-dose MH002
Experimental
High-dose MH002
Interventions: Drug: High-dose MH002
Placebo Comparator
Placebo
Interventions: Drug: Placebo
Interventions
Drug
Low-dose MH002
Microbiome-based live biotherapeutic product consisting of 6 wildtype commensal strains at a dose of 1 × 10\^10 equivalent colony forming units \[eqCFU\]), administered orally (in a capsule) once daily
Drug
High-dose MH002
Microbiome-based live biotherapeutic product consisting of 6 wildtype commensal strains at a dose of 4 × 10\^10 equivalent colony forming units \[eqCFU\]), administered orally (in a capsule) once daily
Drug
Placebo
Blank placebo administered orally (in a capsule) once daily
Eligibility
16 Years and older
All
Not accepted
Inclusion criteria (6)
- Documented diagnosis (histologic diagnosis and either endoscopic or radiographic diagnosis) of ulcerative colitis (UC) at least 3 months prior to Screening.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- UC lesions extending ≥10 cm from the anal verge.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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).Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
Exclusion criteria (21)
- Diagnosis of Crohn's disease, undetermined colitis, ischemic colitis, fulminant colitis, or toxic megacolon.Registry-derived · unreviewed
- Evidence of a clinically significant, active infection of the gastrointestinal tract.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Total colectomy, stoma, or ileo-anal pouch, or history of extensive colonic resection leaving less than 30 cm of colon.Registry-derived · unreviewed
- Presence of intra-abdominal fistula, abscesses, diverticulitis, or gastrointestinal bleeding unrelated to UC.Registry-derived · unreviewed
- History of colon carcinoma or high-grade dysplasia.Registry-derived · unreviewed
- 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).Registry-derived · unreviewed
- Use of sulfasalazine ≤4 weeks prior to randomization.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Use of fecal microbiota transplantation (FMT) ≤52 weeks prior to randomization.Registry-derived · unreviewed
- 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).Registry-derived · unreviewed
- Any immunocompromised state, including conditions linked to severe immunosuppression (eg, active human immunodeficiency virus, malignancies, liver cirrhosis, systemic chemotherapy).Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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).Registry-derived · unreviewed
- Clinically significant bone marrow disease if progressive or not controlled, or any history of solid organ or bone marrow transplantation.Registry-derived · unreviewed
- Active intravenous drug abuse or alcohol abuse disorder as assessed by the Investigator.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Participants who are inappropriate for the study per the Investigator's discretion.Registry-derived · unreviewed
- An employee (or a relative of) of the Investigator, study center, contract research organization, or Sponsor.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Change from baseline in centrally-assessed Mayo Endoscopic Subscore (MES) at Week 12.
Time frame: Week 12
The MES ranges from 0 to 3, with higher scores indicating more severe disease.
Secondary outcome
To confirm the efficacy of MH002 to induce clinical remission at Week 12
Time frame: Week 12
Key secondary endpoint: Clinical remission is defined as a modified Mayo Score (mMS) ≤2, all mMS subscores ≤1, and an Rectal Bleeding (RB) subscore of 0, with endoscopic MES based on worst segment assessed by a blinded central reader, and 2-item Patient-Reported Outcome (PRO-2) scores computed from the e-diary data
Secondary outcome
Change from baseline in histologic scores Robarts' Histopathology Index (RHI) at Week 12
Time frame: Week 12
The RHI score ranges from 0 to 33, with higher scores indicating more severe disease activity.
Secondary outcome
(Median) Percent change from baseline in fecal calprotectin (FC) at Week 12
Time frame: Week 12
Secondary outcome
Change from baseline in UC-100 score at Week 12
Time frame: Week 12
The UC-100 is a composite disease activity index consisting of clinical, endoscopic, and histological findings. The UC-100 score ranges from 1 to 100, with higher scores indicating more severe disease activity.
Secondary outcome
Change from baseline in PRO-2 score at Week 12
Time frame: Week 12
2-item Patient-Reported Outcome (PRO-2) scores computed from the e-diary data on stool frequency and rectal bleed. The PRO-2 score ranges from 0 to 6, with higher scores indicating more severe disease.
Secondary outcome
To confirm the safety and tolerability of MH002 in the Induction Phase
Time frame: Up to Week 12
Incidence of Treatment-Emergent Adverse Events, Serious Adverse events Incidence of Treatment-emergent abnormalities in laboratory parameters and vital signs during 12 weeks treatment period.
Recruiting locations in the United States
ARA Professionals
RecruitingMiami, Florida, 33155, United States
Sergio Rodriguez
Orlando Gastroenterology, P.A.
RecruitingOrlando, Florida, 32835, United States
Sri Pothamsetty
Tropical Clinical Trials
RecruitingPalmetto Bay, Florida, 33176, United States
Michael Feldman
Cross Creek Medical Clinic
RecruitingFayetteville, North Carolina, 28304, United States
Nitinchandra D. Desai
Peters Medical Research
RecruitingHigh Point, North Carolina, 27260, United States
Roy Peters
Southern Star Research Institute
RecruitingSan Antonio, Texas, 78229, United States
Jeff Bullock
This study also lists 10 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Dec 22, 2025
- Primary completion
- Sep 2027
- Overall completion
- May 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.