Frozen stool filtrate treatment for active ulcerative colitis

Longterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitis

This study is testing if a new frozen stool treatment can help people with mild to moderate ulcerative colitis feel better when other treatments haven't worked.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jena University Hospital (Academic / other)
• Drugs / interventions: tofacitinib, filgotinib, upadacitinib, Methotrexate, prednisone
• Locations: 20 sites (Jena, Thuringia and 19 other locations)
• Trial ID: NCT03843385 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of repeated fecal microbiota transplantation (FMT) and fecal microbiota filtrate transplantation (FMFT) in patients with mild to moderate active ulcerative colitis. It is a randomized, double-blind, multicenter trial involving 174 participants who will receive either the treatment or a placebo in oral, frozen capsule form. The primary goal is to assess clinical and endoscopic remission at week 12, while also examining microbial and inflammatory changes post-treatment. The study aims to provide new therapeutic options for patients who have not responded to conventional therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of active ulcerative colitis who have failed conventional therapies.

Not a fit: Patients with severe ulcerative colitis or those who have not undergone prior conventional therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, effective option for managing active ulcerative colitis in patients who have not responded to existing therapies.

How similar studies have performed: Previous studies have shown that fecal microbiota transplantation is effective for certain gastrointestinal conditions, suggesting potential success for this novel application in ulcerative colitis.

Eligibility criteria

Inclusion Criteria:

* Age between 18 and 75 years
* Prior endoscopic confirmation of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge.
* Having active disease, defined with a Mayo Score between 4-10 and Mayo endoscopic subscore \>1
* Failure of conventional therapy or treatment with biologicals and / or small molecules.
* previous medical therapy:

  * oral 5-ASA compounds (5-ASA); stable dosing for 4 weeks before randomization;
  * Azathioprine, 6-Mercaptopurine (6-MP) or Methotrexate (MTX); stable dosing for 8 weeks before randomization;
  * Oral corticosteroid therapy (prednisone ≤ 20 mg/day or budesonide ≤ 9 mg/day); stable dosing for 2 weeks before randomization;
  * Topical therapy (foams, clysms) with mesalazine or budesonide: stable dosing for 2 weeks before randomization.
* previous vaccination against SARS-CoV-2 or previous SARS-CoV-2 infection or positive serology
* Ability to understand and willingness to sign informed consent document in patients whom the investigator believes can and will comply with the requirements of the protocol.
* Potentially childbearing patient: negative pregnancy test and use of a highly effective contraceptive method

Exclusion Criteria:

* Crohn's disease or indeterminate colitis or proctitis ulcerosa alone
* Acute abdomen or other clinical emergencies (e.g. toxic megacolon, fulminant gastrointestinal hemorrhage, ileus, perforation, etc.)
* Previous operations on the colon: colectomy, partial colon resections
* current gastrointestinal infections
* Congenital or acquired immunodeficiency
* severe comorbidity (e.g. insulin-dependent diabetes mellitus, decompensated liver cirrhosis, primary sclerosing cholangitis, renal impairment \> grade 2)
* diagnosis of a malignoma in the last 3 years
* refusal of endoscopies with video documentation
* No specific therapy for ulcerative colitis to date
* Lack of immunity to SARS-CoV-2
* Previous treatment with TNF-, IL12/IL23-, IL23- or integrin-antibodies within the last 8 weeks before randomisation
* Treatment with calcineurin inhibitors within the last 4 weeks before randomization
* Treatment with JAK inhibitors (e.g., tofacitinib, filgotinib, or upadacitinib) within the last 4 weeks prior to randomization
* Treatment with S1P receptor modulators (e.g. ozanimod, etrasimod) within the last 4 weeks before randomization
* Systemic antibiotic treatment within the last 8 weeks prior to randomization.
* Known intolerance of metronidazole or vancomycin
* Previous FMT or FMFT, previous participation in this study (screening allowed)
* Participation in a clinical trial within the last 3 months
* Use of probiotics in tablet, capsule, or powder form, or appropriate drinking yogurts (or similar) within 2 weeks prior to randomization
* Failure to ensure frozen storage of investigational products
* Addictive 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
* Indications that the patient would be unlikely to comply with the protocol (e.g., unwillingness to cooperate - compliance questionable)

Where this trial is running

Jena, Thuringia and 19 other locations

• Jena University Hospital — Jena, Thuringia, Germany (Recruiting)
• Sozialstiftung Bamberg — Bamberg, Germany (Recruiting)
• Charité Berlin — Berlin, Germany (Recruiting)
• DRK Kliniken Berlin Westend — Berlin, Germany (Recruiting)
• Havelhöhe — Berlin, Germany (Recruiting)
• Krankenhaus Waldfriede — Berlin, Germany (Recruiting)
• Universitätsklinikum Carl Gustav Carus Dresden — Dresden, Germany (Recruiting)
• FAU Universität Erlangen-Nürnberg — Erlangen, Germany (Recruiting)
• Agaplesion Markus Krankenhaus — Frankfurt, Germany (Recruiting)
• Universitätsklinik Freiburg — Freiburg im Breisgau, Germany (Recruiting)
• Klinikum Fulda — Fulda, Germany (Recruiting)
• Universitätsklinikum Halle (Saale) — Halle, Germany (Recruiting)
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
• Universitätsklinikum Schleswig Holstein — Kiel, Germany (Recruiting)
• Gesellschaft Klinische Studien Leipzig — Leipzig, Germany (Recruiting)
• St. Marien- und St. Annastiftskrankenhaus — Ludwigshafen, Germany (Recruiting)
• Städtisches Klinikum Lüneburg — Lüneburg, Germany (Recruiting)
• Otto-von-Guericke-Universität - Medizinische Fakultät — Magdeburg, Germany (Recruiting)
• LMU Klinikum München - Campus Großhadern — München, Germany (Recruiting)
• Universitätsklinikum Ulm — Ulm, Germany (Recruiting)

Study contacts

• Study coordinator: Andreas Stallmach, Prof.

Conditions Ulcerative Colitis; Inflammatory Bowel Diseases; fecal transplantation; multidonor fecal transplantation