Actively Recruiting
Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis
Led by Andreas Stallmach · Updated on 2026-02-13
129
Participants Needed
20
Research Sites
217 weeks
Total Duration
On this page
Sponsors
A
Andreas Stallmach
Lead Sponsor
G
German Federal Ministry of Education and Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
FRESCO is a randomized, longitudinal, prospective, three arm, multicentre, double blind study to determine safety and efficacy of repeated faecal microbiota transplantation (FMT) or faecal microbiota filtrate transplantation (FMFT) compared to placebo using oral, frozen capsules in 174 randomized patients with mild to moderate active Ulcerative Colitis.
CONDITIONS
Official Title
Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Endoscopic confirmation of Ulcerative Colitis for at least 6 months with disease extending at least 15 cm from the anal verge
- Active disease with Mayo Score between 4 and 10 and Mayo endoscopic subscore greater than 1
- Failure of conventional therapy or treatment with biologicals or small molecules
- Stable dose of oral 5-ASA compounds for at least 4 weeks before randomization
- Stable dose of Azathioprine, 6-Mercaptopurine, or Methotrexate for at least 8 weeks before randomization
- Stable dose of oral corticosteroids (prednisone ≤ 20 mg/day or budesonide ≤ 9 mg/day) for at least 2 weeks before randomization
- Stable dose of topical mesalazine or budesonide for at least 2 weeks before randomization
- Previous vaccination against SARS-CoV-2, previous SARS-CoV-2 infection, or positive serology
- Ability to understand and willingness to sign informed consent
- For potentially childbearing patients: negative pregnancy test and use of highly effective contraception
You will not qualify if you...
- Diagnosis of Crohn's disease, indeterminate colitis, or proctitis ulcerosa alone
- Acute abdomen or clinical emergencies such as toxic megacolon, severe gastrointestinal bleeding, ileus, or perforation
- Previous colon surgeries including colectomy or partial colon resections
- Current gastrointestinal infections
- Congenital or acquired immunodeficiency
- Severe comorbid conditions such as insulin-dependent diabetes mellitus, decompensated liver cirrhosis, primary sclerosing cholangitis, or renal impairment greater than grade 2
- Diagnosis of malignancy within the last 3 years
- Refusal to undergo endoscopies with video documentation
- No prior specific therapy for Ulcerative Colitis
- Lack of immunity to SARS-CoV-2
- Recent treatment (within specified weeks before randomization) with TNF, IL12/IL23, IL23, or integrin antibodies, calcineurin inhibitors, JAK inhibitors, or S1P receptor modulators
- Systemic antibiotic treatment within 8 weeks prior to randomization
- Known intolerance to metronidazole or vancomycin
- Previous FMT or FMFT treatments or prior participation in this study
- Participation in any clinical trial within the last 3 months
- Use of probiotics in tablet, capsule, or powder form, or similar yogurts within 2 weeks prior to randomization
- Failure to ensure frozen storage of study products
- Addictive or medical conditions impairing understanding or compliance
- Unwillingness or inability to comply with study protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 20 locations
1
Jena University Hospital
Jena, Thuringia, Germany
Actively Recruiting
2
Sozialstiftung Bamberg
Bamberg, Germany
Actively Recruiting
3
Charité Berlin
Berlin, Germany
Actively Recruiting
4
DRK Kliniken Berlin Westend
Berlin, Germany
Actively Recruiting
5
Havelhöhe
Berlin, Germany
Actively Recruiting
6
Krankenhaus Waldfriede
Berlin, Germany
Actively Recruiting
7
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Actively Recruiting
8
FAU Universität Erlangen-Nürnberg
Erlangen, Germany
Actively Recruiting
9
Agaplesion Markus Krankenhaus
Frankfurt, Germany
Actively Recruiting
10
Universitätsklinik Freiburg
Freiburg im Breisgau, Germany
Actively Recruiting
11
Klinikum Fulda
Fulda, Germany
Actively Recruiting
12
Universitätsklinikum Halle (Saale)
Halle, Germany
Actively Recruiting
13
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
14
Universitätsklinikum Schleswig Holstein
Kiel, Germany
Actively Recruiting
15
Gesellschaft Klinische Studien Leipzig
Leipzig, Germany
Actively Recruiting
16
St. Marien- und St. Annastiftskrankenhaus
Ludwigshafen, Germany
Actively Recruiting
17
Städtisches Klinikum Lüneburg
Lüneburg, Germany
Actively Recruiting
18
Otto-von-Guericke-Universität - Medizinische Fakultät
Magdeburg, Germany
Actively Recruiting
19
LMU Klinikum München - Campus Großhadern
München, Germany
Actively Recruiting
20
Universitätsklinikum Ulm
Ulm, Germany
Actively Recruiting
Research Team
A
Andreas Stallmach, Prof.
CONTACT
K
Kathleen Lange, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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