[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07296315":3,"trial-entities:NCT07296315":264,"trial-summary:NCT07296315":268},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":45,"secondary_outcomes":50,"sex":69,"minimum_age":70,"maximum_age":17,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":103,"locations":107,"central_contacts":251,"overall_officials":258,"references":262,"see_also_links":263},"NCT07296315","MH002-UC-202","Confirmatory Clinical Study in Active Ulcerative Colitis","A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Confirm Efficacy and Safety of MH002 and to Assess the Effect of Dose in Patients With Mild-to- Moderate Ulcerative Colitis Insufficiently Controlled With 5-Aminosalicylic Acid","RECRUITING","2028-05","2026-06","2026-07-09","2026-04-03","MRM Health NV","INDUSTRY",true,"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.\n\nMH002 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.",null,[19],"Colitis, Ulcerative",[21,22,23],"5-aminosalicylic-acid","live biotherapeutic product","ulcerative colitis","INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},204,"ESTIMATED",[32,37,41],{"type":33,"name":34,"description":35,"armGroupLabels":36},"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",[34],{"type":33,"name":38,"description":39,"armGroupLabels":40},"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",[38],{"type":33,"name":42,"description":43,"armGroupLabels":44},"Placebo","Blank placebo administered orally (in a capsule) once daily",[42],[46],{"measure":47,"description":48,"timeFrame":49},"Change from baseline in centrally-assessed Mayo Endoscopic Subscore (MES) at Week 12.","The MES ranges from 0 to 3, with higher scores indicating more severe disease.","Week 12",[51,54,57,59,62,65],{"measure":52,"description":53,"timeFrame":49},"To confirm the efficacy of MH002 to induce clinical remission at 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",{"measure":55,"description":56,"timeFrame":49},"Change from baseline in histologic scores Robarts' Histopathology Index (RHI) at Week 12","The RHI score ranges from 0 to 33, with higher scores indicating more severe disease activity.",{"measure":58,"timeFrame":49},"(Median) Percent change from baseline in fecal calprotectin (FC) at Week 12",{"measure":60,"description":61,"timeFrame":49},"Change from baseline in UC-100 score at 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.",{"measure":63,"description":64,"timeFrame":49},"Change from baseline in PRO-2 score at 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.",{"measure":66,"description":67,"timeFrame":68},"To confirm the safety and tolerability of MH002 in the Induction Phase","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.","Up to Week 12","ALL","16 Years",false,{"inclusion":73,"exclusion":80,"raw_text":102},[74,75,76,77,78,79],"Documented diagnosis (histologic diagnosis and either endoscopic or radiographic diagnosis) of ulcerative colitis (UC) at least 3 months prior to Screening.","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.","UC lesions extending ≥10 cm from the anal verge.","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.","Participant must provide written informed consent or assent (parent or legal guardian must provide consent for a participant \\\u003C18 years of age who has assented to participate in the study, or as required per local regulations).","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.",[81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101],"Diagnosis of Crohn's disease, undetermined colitis, ischemic colitis, fulminant colitis, or toxic megacolon.","Evidence of a clinically significant, active infection of the gastrointestinal tract.","Severe UC (mMS\\>7), meeting modified Truelove Witts' criteria and\u002For 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.","Total colectomy, stoma, or ileo-anal pouch, or history of extensive colonic resection leaving less than 30 cm of colon.","Presence of intra-abdominal fistula, abscesses, diverticulitis, or gastrointestinal bleeding unrelated to UC.","History of colon carcinoma or high-grade dysplasia.","Previous use of any advanced UC treatment, including any anti-TNF (eg, infliximab), antiintegrin (eg, vedolizumab) or anti-IL-12\u002F23 (eg, ustekinumab) agent, anti-IL23 (eg, risankizumab), Janus kinase inhibitors (eg, tofacitinib), and sphingosine-1-phosphate receptor modulators (eg, etrasimod).","Use of sulfasalazine ≤4 weeks prior to randomization.","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\u002Fday) for at least 2 weeks prior to Screening colonoscopy and up to at least the Week 12 visit.","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.","Use of fecal microbiota transplantation (FMT) ≤52 weeks prior to randomization.","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).","Any immunocompromised state, including conditions linked to severe immunosuppression (eg, active human immunodeficiency virus, malignancies, liver cirrhosis, systemic chemotherapy).","Leukopenia (total white blood cell count \\\u003C3000\u002FμL) and\u002For neutropenia (absolute neutrophil count \\\u003C1000\u002FμL), anemia (hemoglobin \\\u003C10.0 g\u002FdL), thrombocytopenia (peripheral blood platelet count \\\u003C100 × 10\\^9\u002FL), and\u002For any coagulation disorder with significantly increased risk of bleeding.","Ongoing or recent (\\\u003C3 months) renal disease or insufficiency as manifested, eg, by medical history and\u002For clinical examination and\u002For (calculated or measured) glomerular filtration rate ≤60 mL\u002Fmin.","Ongoing or recent (\\\u003C3 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).","Clinically significant bone marrow disease if progressive or not controlled, or any history of solid organ or bone marrow transplantation.","Active intravenous drug abuse or alcohol abuse disorder as assessed by the Investigator.","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.","Participants who are inappropriate for the study per the Investigator's discretion.","An employee (or a relative of) of the Investigator, study center, contract research organization, or Sponsor.","Inclusion Criteria:\n\n* Documented diagnosis (histologic diagnosis and either endoscopic or radiographic diagnosis) of ulcerative colitis (UC) at least 3 months prior to Screening.\n* 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.\n* UC lesions extending ≥10 cm from the anal verge.\n* 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.\n* Participant must provide written informed consent or assent (parent or legal guardian must provide consent for a participant \\\u003C18 years of age who has assented to participate in the study, or as required per local regulations).\n* 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.\n\nExclusion Criteria:\n\n* Diagnosis of Crohn's disease, undetermined colitis, ischemic colitis, fulminant colitis, or toxic megacolon.\n* Evidence of a clinically significant, active infection of the gastrointestinal tract.\n* Severe UC (mMS\\>7), meeting modified Truelove Witts' criteria and\u002For 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.\n* Total colectomy, stoma, or ileo-anal pouch, or history of extensive colonic resection leaving less than 30 cm of colon.\n* Presence of intra-abdominal fistula, abscesses, diverticulitis, or gastrointestinal bleeding unrelated to UC.\n* History of colon carcinoma or high-grade dysplasia.\n* Previous use of any advanced UC treatment, including any anti-TNF (eg, infliximab), antiintegrin (eg, vedolizumab) or anti-IL-12\u002F23 (eg, ustekinumab) agent, anti-IL23 (eg, risankizumab), Janus kinase inhibitors (eg, tofacitinib), and sphingosine-1-phosphate receptor modulators (eg, etrasimod).\n* Use of sulfasalazine ≤4 weeks prior to randomization.\n* 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\u002Fday) for at least 2 weeks prior to Screening colonoscopy and up to at least the Week 12 visit.\n* 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.\n* Use of fecal microbiota transplantation (FMT) ≤52 weeks prior to randomization.\n* 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).\n* Any immunocompromised state, including conditions linked to severe immunosuppression (eg, active human immunodeficiency virus, malignancies, liver cirrhosis, systemic chemotherapy).\n* Leukopenia (total white blood cell count \\\u003C3000\u002FμL) and\u002For neutropenia (absolute neutrophil count \\\u003C1000\u002FμL), anemia (hemoglobin \\\u003C10.0 g\u002FdL), thrombocytopenia (peripheral blood platelet count \\\u003C100 × 10\\^9\u002FL), and\u002For any coagulation disorder with significantly increased risk of bleeding.\n* Ongoing or recent (\\\u003C3 months) renal disease or insufficiency as manifested, eg, by medical history and\u002For clinical examination and\u002For (calculated or measured) glomerular filtration rate ≤60 mL\u002Fmin.\n* Ongoing or recent (\\\u003C3 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).\n* Clinically significant bone marrow disease if progressive or not controlled, or any history of solid organ or bone marrow transplantation.\n* Active intravenous drug abuse or alcohol abuse disorder as assessed by the Investigator.\n* 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.\n* Participants who are inappropriate for the study per the Investigator's discretion.\n* An employee (or a relative of) of the Investigator, study center, contract research organization, or Sponsor.",[104,105,106],"CHILD","ADULT","OLDER_ADULT",[108,121,131,141,152,162,173,184,194,201,207,214,221,228,234,240],{"facility":109,"status":8,"city":110,"state":111,"zip":112,"country":113,"contacts":114,"geoPoint":118},"ARA Professionals","Miami","Florida","33155","United States",[115],{"name":116,"role":117},"Sergio Rodriguez","CONTACT",{"lat":119,"lon":120},25.77427,-80.19366,{"facility":122,"status":8,"city":123,"state":111,"zip":124,"country":113,"contacts":125,"geoPoint":128},"Orlando Gastroenterology, P.A.","Orlando","32835",[126],{"name":127,"role":117},"Sri Pothamsetty",{"lat":129,"lon":130},28.53834,-81.37924,{"facility":132,"status":8,"city":133,"state":111,"zip":134,"country":113,"contacts":135,"geoPoint":138},"Tropical Clinical Trials","Palmetto Bay","33176",[136],{"name":137,"role":117},"Michael Feldman",{"lat":139,"lon":140},25.62177,-80.32477,{"facility":142,"status":8,"city":143,"state":144,"zip":145,"country":113,"contacts":146,"geoPoint":149},"Cross Creek Medical Clinic","Fayetteville","North Carolina","28304",[147],{"name":148,"role":117},"Nitinchandra D. Desai",{"lat":150,"lon":151},35.05266,-78.87836,{"facility":153,"status":8,"city":154,"state":144,"zip":155,"country":113,"contacts":156,"geoPoint":159},"Peters Medical Research","High Point","27260",[157],{"name":158,"role":117},"Roy Peters",{"lat":160,"lon":161},35.95569,-80.00532,{"facility":163,"status":8,"city":164,"state":165,"zip":166,"country":113,"contacts":167,"geoPoint":170},"Southern Star Research Institute","San Antonio","Texas","78229",[168],{"name":169,"role":117},"Jeff Bullock",{"lat":171,"lon":172},29.42412,-98.49363,{"facility":174,"status":8,"city":175,"zip":176,"country":177,"contacts":178,"geoPoint":181},"JSC Georgian Clinics","Kutaisi","4600","Georgia",[179],{"name":180,"role":117},"Davit Jugeli",{"lat":182,"lon":183},42.26791,42.69459,{"facility":185,"status":8,"city":186,"zip":187,"country":177,"contacts":188,"geoPoint":191},"American Hospital Network LLC","Tbilisi","0102",[189],{"name":190,"role":117},"Tengiz Telia",{"lat":192,"lon":193},41.69143,44.83412,{"facility":195,"status":8,"city":186,"zip":196,"country":177,"contacts":197,"geoPoint":200},"K. Eristavi National Center of Experimental and Clinical Surgery JSC","0159",[198],{"name":199,"role":117},"Tamta Nikolaishvili",{"lat":192,"lon":193},{"facility":202,"status":8,"city":186,"zip":196,"country":177,"contacts":203,"geoPoint":206},"LTD Institute of Clinical Cardiology",[204],{"name":205,"role":117},"Irina Jashi",{"lat":192,"lon":193},{"facility":208,"status":8,"city":186,"zip":209,"country":177,"contacts":210,"geoPoint":213},"Aversi Clinic LLC","0160",[211],{"name":212,"role":117},"Nino Kiknadze",{"lat":192,"lon":193},{"facility":215,"status":8,"city":186,"zip":216,"country":177,"contacts":217,"geoPoint":220},"LEPL The First University Clinic of Tbilisi State Medical University","0178",[218],{"name":219,"role":117},"Giga Sordia",{"lat":192,"lon":193},{"facility":222,"status":8,"city":186,"zip":223,"country":177,"contacts":224,"geoPoint":227},"LLC The First Medical Center","0180",[225],{"name":226,"role":117},"Ekaterine Labadze",{"lat":192,"lon":193},{"facility":229,"status":8,"city":186,"zip":223,"country":177,"contacts":230,"geoPoint":233},"LTD Krol Medical Corporation",[231],{"name":232,"role":117},"Rusudan Shonia",{"lat":192,"lon":193},{"facility":235,"status":8,"city":186,"zip":223,"country":177,"contacts":236,"geoPoint":239},"Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC",[237],{"name":238,"role":117},"Khatuna Gargulia",{"lat":192,"lon":193},{"facility":241,"status":8,"city":242,"zip":243,"country":244,"contacts":245,"geoPoint":248},"PMSI \"Timofei Mosneaga\" Republican Clinical Hospital","Chisinau","MD2025","Moldova",[246],{"name":247,"role":117},"Victoria Babitchi",{"lat":249,"lon":250},47.00902,28.85938,[252,256],{"name":253,"role":117,"phone":254,"email":255},"Jean-Michel Muhlinghaus, DVM","+32 9 277 08 50","clinicaltrials@mrmhealth.com",{"name":257,"role":117,"phone":254},"Carmen Fleurinck, MD",[259],{"name":260,"affiliation":13,"role":261},"Ludo Haazen, MD","STUDY_CHAIR",[],[],{"nct_id":4,"conditions":265,"biomarkers":267},[266],"Ulcerative Colitis",[],{"nct_id":4,"found":15,"summary":269,"prompt_version":279},{"design":270,"status":271,"heading":272,"summary":273,"follow_up":274,"word_count":275,"commitments":276,"compensation":277,"drugs_mentioned":278},"This interventional study plans to enroll 204 participants. It will test two different doses of MH002 against a placebo.","completed","Confirmatory Study of MH002 for Active Ulcerative Colitis","This study is testing MH002, a microbiome-based live biotherapeutic product (a medicine with live bacteria) for people with active ulcerative colitis (UC). UC is a bowel disease causing inflammation and sores. MH002 aims to restore normal gut function. Researchers want to see if MH002 is safe and effective. Two different doses of MH002, given as a capsule once daily, will be compared to a placebo (an inactive capsule). You may be able to join if you are at least 16 years old and have been diagnosed with active mild-to-moderate UC for at least three months. The main goal is to see how much your colon's inflammation improves after 12 weeks.","The primary outcome is measured at Week 12. Long-term treatment effects will be investigated, but specific follow-up duration is not detailed.",110,"Participants will take an oral capsule once daily. The primary endpoint is measured at Week 12, suggesting at least 12 weeks of participation.","Not stated in the trial record.",[42],"v2"]