Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis

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

Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis (NCT03843385) is a Phase 3 interventional studying Ulcerative Colitis and Inflammatory Bowel Diseases, sponsored by Andreas Stallmach. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Ulcerative Colitis, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 129 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Ulcerative Colitis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 weakened immune system - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

DRUG

encapsulated faecal microbiota filtrate

Multidonor stool mixed with sterile normal saline, homogenized, filtered, centrifuged, air pressure filtered, encapsulated in hypromellose capsules and frozen.

DRUG

encapsulated faecal microbiota

Multidonor stool mixed with sterile normal saline, homogenized, filtered, encapsulated in hypromellose capsules and frozen.

DRUG

Placebo

Sterile saline encapsulated in hypromellose capsules and frozen.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Jena University Hospital

Jena, Thuringia, Germany

Sozialstiftung Bamberg

Bamberg, Germany

Charité Berlin

Berlin, Germany

DRK Kliniken Berlin Westend

Berlin, Germany

Havelhöhe

Berlin, Germany

Krankenhaus Waldfriede

Berlin, Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

FAU Universität Erlangen-Nürnberg

Erlangen, Germany

Agaplesion Markus Krankenhaus

Frankfurt, Germany

Universitätsklinik Freiburg

Freiburg im Breisgau, Germany

Klinikum Fulda

Fulda, Germany

Universitätsklinikum Halle (Saale)

Halle, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Universitätsklinikum Schleswig Holstein

Kiel, Germany

Gesellschaft Klinische Studien Leipzig

Leipzig, Germany

St. Marien- und St. Annastiftskrankenhaus

Ludwigshafen, Germany

Städtisches Klinikum Lüneburg

Lüneburg, Germany

Otto-von-Guericke-Universität - Medizinische Fakultät

Magdeburg, Germany

LMU Klinikum München - Campus Großhadern

München, Germany

Universitätsklinikum Ulm

Ulm, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT03843385), the sponsor (Andreas Stallmach), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT03843385 clinical trial studying?

Who can participate in NCT03843385?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT03843385?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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Source: ClinicalTrials.gov API v2 record for NCT03843385. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT03843385. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.