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Ulcerative ColitisPhase 3FRESCONCT03843385

Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis

A Phase 3 study testing encapsulated faecal microbiota filtrate and encapsulated faecal microbiota in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Andreas Stallmach at 20 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
encapsulated faecal microbiota filtrate and encapsulated faecal microbiota
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
20 sitesGermany
Study dates
31 Jan 2023to Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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

Who cannot join

  • 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)
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  • 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)

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Germany20 sites

  • Sozialstiftung Bamberg

    Bamberg

  • Charité Berlin

    Berlin

  • DRK Kliniken Berlin Westend

    Berlin

  • Havelhöhe

    Berlin

  • Krankenhaus Waldfriede

    Berlin

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden

  • FAU Universität Erlangen-Nürnberg

    Erlangen

  • Agaplesion Markus Krankenhaus

    Frankfurt

  • Universitätsklinik Freiburg

    Freiburg im Breisgau

  • Klinikum Fulda

    Fulda

  • Universitätsklinikum Halle (Saale)

    Halle

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Jena University Hospital

    Jena, Thuringia

  • Universitätsklinikum Schleswig Holstein

    Kiel

  • Gesellschaft Klinische Studien Leipzig

    Leipzig

  • St. Marien- und St. Annastiftskrankenhaus

    Ludwigshafen

  • Städtisches Klinikum Lüneburg

    Lüneburg

  • Otto-von-Guericke-Universität - Medizinische Fakultät

    Magdeburg

  • LMU Klinikum München - Campus Großhadern

    München

  • Universitätsklinikum Ulm

    Ulm

Other trials in Germany

About this study

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

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.

Read the detailed description

Ulcerative colitis (UC) is a chronic inflammatory bowel disease with significant morbidity and mortality. Although the precise cause remains unknown, disturbances in the intestinal microbial community and changes in the crosstalk between the microbiota and the mucosal immune system have been linked to its pathogenesis. As current therapies are limited, there is a medical need for new therapies. Faecal microbiota transplantation (FMT) has been proven to be effective in managing relapsing Clostridium difficile infection (CDI) and preliminary results indicated that also the transfer of filtrates of donor stool (FMFT) drives gastrointestinal microbiota changes and eliminate symptoms in CDI patients. FRESCO is a randomized, longitudinal, prospective, three arm, multicentre, double blind study to determine safety and efficacy of repeated FMT or FMFT compared to placebo using oral, frozen capsules in 174 randomized patients with mild to moderate active UC. The primary outcome will be clinical and endoscopic remission at week 12. This proposal aims to examine: (a) the efficacy of FMT / FMFT as a therapy for active UC, (b) the safety of FMT / FMFT in patients with UC and (c) the microbial and inflammable changes that occur after FMT / FMFT, to help understand how and why it works in this group of patients. All analyses will be conducted in both intention-to-treat (primary) and per-protocol (sensitivity analyses) populations, and the differences in remission rates and relapse rates between the groups will be statistically analysed to determine the efficiency of FMT versus FMFT.

Being tested
encapsulated faecal microbiota filtrate, encapsulated faecal microbiota, Placebo
Keywords
fecal transplantation, multidonor fecal transplantation
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • encapsulated faecal microbiota filtrateDrug

    Also called FMFT

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

  • encapsulated faecal microbiotaDrug

    Also called FMT

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

  • PlaceboDrug

    Also called Encapsulated sterile saline

    Sterile saline encapsulated in hypromellose capsules and frozen.

Study groups in NCT03843385
Study groupRoleWhat they receive
faecal microbiota filtrateExperimentalEncapsulated faecal microbiota filtrate . 2×5 frozen capsules by mouth on 5 consecutive days per week (5 days on and 2 days off; week 1 - week 12) with water or cool drink.
Receives: Drug: encapsulated faecal microbiota filtrate
faecal microbiotaActive comparatorEncapsulated faecal microbiota. 2×5 frozen capsules by mouth on 5 consecutive days per week (5 days on and 2 days off; week 1 - week 12) with water or cool drink.
Receives: Drug: encapsulated faecal microbiota
PlaceboSham comparatorPlacebo: Encapsulated sterile saline. 2×5 frozen capsules by mouth on 5 consecutive days per week (5 days on and 2 days off; week 1 - week 12) with water or cool drink.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. clinical remission

    The primary outcome will be clinical remission at week 12 post first transfer of FMFT or FMT, defined by Mayo score ≤ 2, all subscores ≤ 1; additionally patients unavailable at the week 12 follow-up will be included as non-responders (i.e. counted no remission).

    Measured: 12 weeks

Secondary outcomes (10)

  1. steroid-free clinical remission

    steroid-free clinical remission at week 12 post first transfer of FMFT or FMT, with a minimum of steroid free time of 4 weeks (week 8 to 12)

    Measured: 12 weeks

  2. clinical response

    clinical response is defined by decrease in partial Mayo score by more than 3 points and a minimum decrease of 30% from output value and additional bleeding subscore by more than 1 point or absolute sub-score of 0-1

    Measured: 12 weeks

  3. change in quality of life

    quality of life is assessed at week 0,4,8,12 for short-term efficacy and for long-term efficacy at week 24,36 and 52 post first transfer by Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ). The IBDQ is a 32-item self-rated questionnaire with 4 domains (bowel symptoms, emotional function, social function, systemic symptoms). Each item is rated on a seven-point Likert Scale. The total score ranges from 32 to 224 points with higher scores reflecting better well-being.

    Measured: 52 weeks

  4. endoscopic remission

    endoscopic remission at week 12 post first transfer of FMFT or FMT, with a score between 0 and 3, (0 = Normal or inactive disease, 1 = mild inflammatory activity, 2 = moderate disease, 3 = severe disease)

    Measured: 12 weeks

  5. mucosal inflammation - measured through fecal calprotectin

    mucosal inflammation in stool samples at week 0, 4, 8, 12, 24, 36, 52 post first transfer of FMFT or FMT

    Measured: 52 weeks

  6. microbiome analysis

    analysis of stool samples at week 0, 4, 8, 12, 24, 36, 52 post first transfer of FMFT or FMT regarding microbiome diversity and composition

    Measured: 52 weeks

  7. virome analysis

    analysis of stool samples at week 0, 4, 8, 12, 24, 36, 52 post first transfer of FMFT or FMT regarding virome composition

    Measured: 52 weeks

  8. MAYO Total Score

    Comparison of the MAYO total Score between the 3 Arms (FMFT, FMT and Placebo)

    Measured: 52 weeks

  9. Histological mucosal inflammation - Nancy index

    Analysis of obtained mucosa biopsies at week 0 and 12, regarding disease activity graded with the Nancy index

    Measured: 12 weeks

  10. Safety - adverse events and severe adverse events

    adverse events and severe adverse events in the different treatment arms will be recorded

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2019
  2. Study start31 Jan 2023
  3. Primary completionAug 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized to receive intensive dosing multi-donor FMFT or FMT as therapeutic strategies or saline as a placebo comparator. To achieve balanced distributions for pretreatment factors, we propose to apply stratified (stratum 1: "biologicals yes/no"; stratum 2: "participating centre") block randomization.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03843385
Sponsor's protocol ID
KS2017-114
Acronym
FRESCO
Status last verified
Feb 2026
First submitted
14 Feb 2019
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stallmach A, Grunert P, Stallhofer J, Loffler B, Baier M, Rodel J, Kiehntopf M, Neugebauer S, Pieper DH, Junca H, Tannapfel A, Merkel U, Schumacher U, Breternitz-Gruhne M, Heller T, Schauer A, Hartmann M, Steube A. Transfer of FRozen Encapsulated multi-donor Stool filtrate for active ulcerative Colitis (FRESCO): study protocol for a prospective, multicenter, double-blind, randomized, controlled trial. Trials. 2022 Feb 22;23(1):173. doi: 10.1186/s13063-022-06095-1.

    PubMed 35193638

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing encapsulated faecal microbiota filtrate and encapsulated faecal microbiota in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Andreas Stallmach at 20 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical remission (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03843385, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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