Clinical trial • Phase III • Gastroenterology
ALLOGENEIC FAECAL MICROBIOTA, POOLED for Ulcerative colitis
Phase III trial of ALLOGENEIC FAECAL MICROBIOTA, POOLED for Ulcerative colitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Ulcerative colitis
- Trial Stage
- Phase III
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 14-10-2024
- First CTIS Authorization Date
- 08-11-2024
Trial design
Randomised, arms: fecal microbiome (fm) (test product: allogeneic faecal microbiota, pooled; capsules for oral use; max daily amount 6000 µl, max total amount 360 ml, max treatment period 12 months), fecal microbiome filtrate (fmf) (test product: allogeneic faecal microbiota, pooled; capsules for oral use; max daily amount 6000 µl, max total amount 360 ml, max treatment period 12 months) versus placebo, unauthorised capsule, hard for oral use. auxiliary antibiotics listed in trial (vancomycin, metronidazole) but dosing/schedule not specified in the provided trial summary.-controlled Phase III trial across 21 sites in Germany.
- Randomised
- Yes
- Comparator
- Arms: Fecal microbiome (FM) (test product: allogeneic faecal microbiota, pooled; capsules for oral use; max daily amount 6000 µl, max total amount 360 ml, max treatment period 12 months), Fecal Microbiome Filtrate (FMF) (test product: allogeneic faecal microbiota, pooled; capsules for oral use; max daily amount 6000 µl, max total amount 360 ml, max treatment period 12 months) versus Placebo, unauthorised capsule, hard for oral use. Auxiliary antibiotics listed in trial (vancomycin, metronidazole) but dosing/schedule not specified in the provided trial summary.
- Target Sample Size
- 129
- Trial Duration For Participant
- 365
Eligibility
Recruits 129 Vulnerable population not selected. Participants must be able to understand study procedures and provide written consent (inclusion criteria: written consent; ability to understand study procedures). Participants are adults (age between 18 and 75 years); no assent process described..
- Pregnancy Exclusion
- • potentially childbearing patient: negative pregnancy test and use of a highly effective contraceptive method
- Vulnerable Population
- Vulnerable population not selected. Participants must be able to understand study procedures and provide written consent (inclusion criteria: written consent; ability to understand study procedures). Participants are adults (age between 18 and 75 years); no assent process described.
Inclusion criteria
- {"criterion_text":"- •\tAge between 18 and 75 years"}
- {"criterion_text":"- •\twritten consent"}
- {"criterion_text":"- •\tprior endoscopic confirmation of colitis ulcerosa (first diagnosis of at least 6 months, active disease: mayo score between 4-10 points at screening, documented endoscopic minimum disease extent of 15 cm from the anal verge (mayo endoskopic subscore >1)"}
- {"criterion_text":"- •\tFailure of conventional therapy or treatment with biologicals and/or small molecules"}
- {"criterion_text":"- •\tprevious medical therapy: -oral 5-ASA compounds (5-ASA) (stable dose for 4 weeks before randomisation) OR -Azathioprine, 6-MP or MTX (stable dose for 8 weeks before randomisation) OR -oral steroid therapy: (prednisone (≤ 20 mg/day) or budesonide (≤ 9 mg/day)) (stable dose for 2 weeks before randomisation) OR -topical therapy (foams, clysms) with mesalazine or budesonide (stable dose for 2 weeks before randomisation)"}
- {"criterion_text":"- •\tprevious vaccination against SARS-CoV-2 or previous SARS-CoV-2 infection or positive serology"}
- {"criterion_text":"- •\tAbility to understand study procedures and willingness to meet requirements associated with participation (e. g. endoscopy, intake antibiotics)"}
- {"criterion_text":"- •\tpotentially childbearing patient: negative pregnancy test and use of a highly effective contraceptive method"}
Exclusion criteria
- {"criterion_text":"- •\tCrohn´s disease, indeterminate colitis or ulcerative proctitis (< 15 cm ab ano)"}
- {"criterion_text":"- •\tlack of immunity to SARS-CoV-2"}
- {"criterion_text":"- •\tPrevious treatment with TNF-, IL12/IL23-, IL23- or integrin-antibodies (8 weeks before randomisation)"}
- {"criterion_text":"- •\tTreatment with calcineurin inhibitors (4 weeks before randomization)"}
- {"criterion_text":"- •\tTreatment with JAK inhibitors (e.g., tofacitinib, filgotinib, or upadacitinib) (4 weeks before randomization)"}
- {"criterion_text":"- •\tTreatment with S1P receptor modulator (e. g. ozanimod, etrasimod) (4 weeks before randomization)"}
- {"criterion_text":"- •\tSystemic antibiotic treatment (8 weeks before randomization)"}
- {"criterion_text":"- •\tKnown intolerance to metronidazole or vancomycin"}
- {"criterion_text":"- •\tParticipation in a clinical trial (3 months before randomization)"}
- {"criterion_text":"- •\tPrevious FMT or FMFT, previous participation in this study (screening allowed)"}
- {"criterion_text":"- •\tUse of probiotics in tablet, capsule, or powder form, or appropriate drinking yogurts (or similar) (2 weeks before randomization)"}
- {"criterion_text":"- •\tAcute abdomen or other clinical emergencies (toxic megacolon, fulminant gastrointestinal hemorrhage, ileus, perforation, etc.)"}
- {"criterion_text":"- •\tFailure to ensure frozen storage of investigational products: no possibility to store capsules at ≤ -10°C, planned longer absence (12 weeks after randomization)"}
- {"criterion_text":"- •\tAddictive or other medical conditions or circumstances that do not allow the subject to appreciate the nature, significance, scope, and possible consequences of the clinical trial"}
- {"criterion_text":"- •\tIndications that the patient would be unlikely to comply with the protocol (e.g., unwillingness to cooperate - compliance questionable)"}
- {"criterion_text":"- •\tPrevious operations on the colon: colectomy, partial colon resections"}
- {"criterion_text":"- •\tcurrent gastrointestinal infections (e. g. Clostridium difficile infection, CMV infection) until randomisation"}
- {"criterion_text":"- •\tCongenital or acquired immunodeficiency"}
- {"criterion_text":"- •\tsevere comorbidity (e.g. insulin-dependent diabetes mellitus, decompensated liver cirrhosis, primary sclerosing cholangitis, renal impairment > grade 2)"}
- {"criterion_text":"- •\tdiagnosis of a malignoma in the last 3 years"}
- {"criterion_text":"- •\trefusal of endoscopies with video documentation"}
- {"criterion_text":"- •\tNo specific therapy for ulcerative colitis to date"}
Endpoints
Primary endpoints
- {"endpoint_text":"- clinical remission at week 12 post transfer defined by Mayo score ≤ 2 and any subcore ≤ 1, missing values to week 12 are considered as no remission","definition_or_measurement_approach":"Defined by Mayo score ≤ 2 and any subcore ≤ 1; missing values to week 12 are considered as no remission."}
Secondary endpoints
- {"endpoint_text":"- steroid-free clinical remission","definition_or_measurement_approach":"Steroid-free clinical remission (no additional definition provided)."}
- {"endpoint_text":"- Mayo score","definition_or_measurement_approach":"Measured using the Mayo score."}
- {"endpoint_text":"- endoscopic remission","definition_or_measurement_approach":"Endoscopic remission (no additional definition provided)."}
- {"endpoint_text":"- clinical response","definition_or_measurement_approach":"Clinical response (no additional definition provided)."}
- {"endpoint_text":"- mucosal infammation (fecal calprotectin)","definition_or_measurement_approach":"Measured by fecal calprotectin."}
- {"endpoint_text":"- histological mucosal inflammation (Nancy index)","definition_or_measurement_approach":"Measured using the Nancy histology index."}
- {"endpoint_text":"- quality of life","definition_or_measurement_approach":"Quality of life (no specific instrument defined in provided data)."}
- {"endpoint_text":"- microbiome and virome analysis","definition_or_measurement_approach":"Microbiome and virome analyses (methods not specified in provided data)."}
- {"endpoint_text":"- safety","definition_or_measurement_approach":"Safety (no further definition provided)."}
Recruitment
- Registry Or Advocacy Recruitment
- Yes
- Planned Sample Size
- 129
- Recruitment Window Months
- 51
- Consent Approach
- Written informed consent required from participants (inclusion criterion: written consent). Participants must be aged 18-75. Subject information and informed consent form documents are listed among trial documents (L1 files). A German translation of some materials/criteria is present.
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 129
Germany
- Earliest CTIS Part Ii Submission Date
- 23-10-2024
- Latest Decision Or Authorization Date
- 12-01-2026
- Processing Time Days
- 446
- Number Of Sites
- 21
- Number Of Participants
- 129
Sites
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Innere Medizin I
- Principal Investigator Name
- Jochen Klaus
- Principal Investigator Email
- jochen.klaus@uniklinik-ulm.de
- Contact Person Name
- Jochen Klaus
- Contact Person Email
- jochen.klaus@uniklinik-ulm.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Medizinische Klinik 1
- Principal Investigator Name
- Raja Atreya
- Principal Investigator Email
- Raja.Atreya@uk-erlangen.de
- Contact Person Name
- Raja Atreya
- Contact Person Email
- Raja.Atreya@uk-erlangen.de
- Site Name
- Otto Von Guericke Universitaet Magdeburg
- Department Name
- Zentrum für Innere Medizin
- Principal Investigator Name
- Ulrike von Arnim
- Principal Investigator Email
- ulrike.vonarnim@med.ovgu.de
- Contact Person Name
- Ulrike von Arnim
- Contact Person Email
- ulrike.vonarnim@med.ovgu.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Klinik für Innere Medizin IV
- Principal Investigator Name
- Andreas Stallmach
- Principal Investigator Email
- andreas.stallmach@med.uni-jena.de
- Contact Person Name
- Andreas Stallmach
- Contact Person Email
- andreas.stallmach@med.uni-jena.de
- Site Name
- Sozialstiftung Bamberg
- Department Name
- Klinik für Integrative Medizin und Naturheilkunde
- Principal Investigator Name
- Jost Langhorst
- Principal Investigator Email
- FIGN@sozialstiftung-bamberg.de
- Contact Person Name
- Jost Langhorst
- Contact Person Email
- FIGN@sozialstiftung-bamberg.de
- Site Name
- Klinikum Fulda gAG
- Department Name
- Medizinische Klinik II
- Principal Investigator Name
- Carsten Schmidt
- Principal Investigator Email
- Carsten.Schmidt@klinikum-fulda.de
- Contact Person Name
- Carsten Schmidt
- Contact Person Email
- Carsten.Schmidt@klinikum-fulda.de
- Site Name
- St. Marien Und St. Annastiftskrankenhaus
- Department Name
- Klinik für Innere Medizin
- Principal Investigator Name
- Tanja Kühbacher
- Principal Investigator Email
- studienabteilung@st-marienkrankenhaus.de
- Contact Person Name
- Tanja Kühbacher
- Contact Person Email
- studienabteilung@st-marienkrankenhaus.de
- Site Name
- Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselerkrankungen (IGVS)
- Department Name
- Gesellschaft für Klinische Studien
- Principal Investigator Name
- Niels Teich
- Principal Investigator Email
- teich@igvs.de
- Contact Person Name
- Niels Teich
- Contact Person Email
- teich@igvs.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Innere Medizin II
- Principal Investigator Name
- Peter Hasselblatt
- Principal Investigator Email
- peter.hasselblatt@uniklinik-freiburg.de
- Contact Person Name
- Peter Hasselblatt
- Contact Person Email
- peter.hasselblatt@uniklinik-freiburg.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik für Gastroenterologie, Infektiologie und Rheumatologie
- Principal Investigator Name
- Britta Siegmund
- Principal Investigator Email
- britta.siegmund@charite.de
- Contact Person Name
- Britta Siegmund
- Contact Person Email
- britta.siegmund@charite.de
- Site Name
- Agaplesion Frankfurter Diakonie Kliniken gGmbH
- Department Name
- Medizinische Klinik I
- Principal Investigator Name
- Axel Dignaß
- Principal Investigator Email
- axel.dignass@agaplesion.de
- Contact Person Name
- Axel Dignaß
- Contact Person Email
- axel.dignass@agaplesion.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Medizinisches Zentrum I
- Principal Investigator Name
- Claudia Veltkamp
- Principal Investigator Email
- Claudia.Veltkamp@uk-essen.de
- Contact Person Name
- Claudia Veltkamp
- Contact Person Email
- Claudia.Veltkamp@uk-essen.de
- Site Name
- Gemeinschaftskrankenhaus Havelhoehe gGmbH
- Department Name
- Gastroenterologie/Diabetologie/Ernährungsmedizin
- Principal Investigator Name
- Markus Wispler
- Principal Investigator Email
- Markus.Wispler@havelhoehe.de
- Contact Person Name
- Markus Wispler
- Contact Person Email
- Markus.Wispler@havelhoehe.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Medizinische Klinik I
- Principal Investigator Name
- Thorben Fründt
- Principal Investigator Email
- t.fruendt@uke.de
- Contact Person Name
- Thorben Fründt
- Contact Person Email
- t.fruendt@uke.de
- Site Name
- Staedtisches Klinikum Lueneburg gGmbH
- Department Name
- Innere Medizin
- Principal Investigator Name
- Christian Maaser
- Principal Investigator Email
- christian.maaser@klinikum-lueneburg.de
- Contact Person Name
- Christian Maaser
- Contact Person Email
- christian.maaser@klinikum-lueneburg.de
- Site Name
- DRK Kliniken Berlin
- Department Name
- Klinik für Innere Medizin
- Principal Investigator Name
- Andreas Sturm
- Principal Investigator Email
- a.sturm@drk-kliniken-berlin.de
- Contact Person Name
- Andreas Sturm
- Contact Person Email
- a.sturm@drk-kliniken-berlin.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Medizinische Klinik und Poliklinik I
- Principal Investigator Name
- Renate Schmelz
- Principal Investigator Email
- schmelz.studien@ukdd.de
- Contact Person Name
- Renate Schmelz
- Contact Person Email
- schmelz.studien@ukdd.de
- Site Name
- Krankenhaus Waldfriede e.V.
- Department Name
- Innere Abteilung
- Principal Investigator Name
- Carsten Büning
- Principal Investigator Email
- C.Buening@waldfriede.de
- Contact Person Name
- Carsten Büning
- Contact Person Email
- C.Buening@waldfriede.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für Innere Medizin
- Principal Investigator Name
- Stefan Schreiber
- Principal Investigator Email
- s.schreiber@ikmb.uni-kiel.de
- Contact Person Name
- Stefan Schreiber
- Contact Person Email
- s.schreiber@ikmb.uni-kiel.de
- Site Name
- Martin-Luther-Universitaet Halle-Wittenberg
- Department Name
- Universitätsklinik und Poliklinik für Innere Medizin I
- Principal Investigator Name
- Jens Walldorf
- Principal Investigator Email
- jens.walldorf@uk-halle.de
- Contact Person Name
- Jens Walldorf
- Contact Person Email
- jens.walldorf@uk-halle.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Medizinische Klinik und Poliklinik II
- Principal Investigator Name
- Helga Török
- Principal Investigator Email
- helga.toeroek@med.uni-muenchen.de
- Contact Person Name
- Helga Török
- Contact Person Email
- helga.toeroek@med.uni-muenchen.de
Sponsor
Primary sponsor
- Full Name
- Friedrich-Schiller-Universitaet Jena
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Fecal microbiome (FM)
- Active Substance
- ALLOGENEIC FAECAL MICROBIOTA, POOLED
- Modality
- Other
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised
- Maximum Dose
- 6000 µl per day; max total 360 ml
- Investigational Product Name
- Fecal Microbiome Filtrate (FMF)
- Active Substance
- ALLOGENEIC FAECAL MICROBIOTA, POOLED
- Modality
- Other
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised
- Maximum Dose
- 6000 µl per day; max total 360 ml
- Investigational Product Name
- Placebo, unauthorised capsule, hard for oral use
- Modality
- Other
- Authorisation Status
- Unauthorised
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