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Frozen poop pills could tame ulcerative colitis

NCT ID NCT03843385

Disease control Sponsor: Andreas Stallmach Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study tests whether frozen capsules containing processed stool from healthy donors can help people with mild-to-moderate active ulcerative colitis. Participants will take either the real capsules or a placebo for 12 weeks. The goal is to see if the treatment can bring the disease into remission without the need for ongoing strong medications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
frozen stool capsules (fecal microbiota transplant or filtrate)
What this could lead to
If it works, this could offer a new, non-drug way to control ulcerative colitis and reduce symptoms without long-term medication.
What could go wrong
This is a phase 3 trial, but results are not yet known. The treatment may not work better than placebo, and some people may not respond or could have side effects like bloating or infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

84 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inflammatory bowel diseases Ulcerative colitis

Contacts and locations

Locations

  • Agaplesion Markus Krankenhaus

    Frankfurt, Germany

  • Charité Berlin

    Berlin, Germany

  • DRK Kliniken Berlin Westend

    Berlin, Germany

  • FAU Universität Erlangen-Nürnberg

    Erlangen, Germany

  • Gesellschaft Klinische Studien Leipzig

    Leipzig, Germany

  • Havelhöhe

    Berlin, Germany

  • Jena University Hospital

    Jena, Thuringia, Germany

  • Klinikum Fulda

    Fulda, Germany

  • Krankenhaus Waldfriede

    Berlin, Germany

  • LMU Klinikum München - Campus Großhadern

    München, Germany

  • Otto-von-Guericke-Universität - Medizinische Fakultät

    Magdeburg, Germany

  • Sozialstiftung Bamberg

    Bamberg, Germany

  • St. Marien- und St. Annastiftskrankenhaus

    Ludwigshafen, Germany

  • Städtisches Klinikum Lüneburg

    Lüneburg, Germany

  • Universitätsklinik Freiburg

    Freiburg im Breisgau, Germany

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, Germany

  • Universitätsklinikum Halle (Saale)

    Halle, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Germany

  • Universitätsklinikum Schleswig Holstein

    Kiel, Germany

  • Universitätsklinikum Ulm

    Ulm, Germany

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