NCT03843385

Brief 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 moderate active Ulcerative Colitis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P25-P50 for phase_3

Timeline
11mo left

Started Jan 2023

Typical duration for phase_3

Geographic Reach
1 country

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jan 2023Apr 2027

First Submitted

Initial submission to the registry

February 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
4 years until next milestone

Study Start

First participant enrolled

January 31, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

3.4 years

First QC Date

February 14, 2019

Last Update Submit

February 11, 2026

Conditions

Inflammatory Bowel DiseasesUlcerative Colitis

Keywords

fecal transplantationmultidonor fecal transplantation

Outcome Measures

Primary Outcomes (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).

    12 weeks

Secondary Outcomes (10)

  • steroid-free clinical remission

    12 weeks

  • clinical response

    12 weeks

  • change in quality of life

    52 weeks

  • endoscopic remission

    12 weeks

  • mucosal inflammation - measured through fecal calprotectin

    52 weeks

  • +5 more secondary outcomes

Study Arms (3)

faecal microbiota filtrate

EXPERIMENTAL

Encapsulated 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.

Drug: encapsulated faecal microbiota filtrate

faecal microbiota

ACTIVE COMPARATOR

Encapsulated 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.

Drug: encapsulated faecal microbiota

Placebo

SHAM COMPARATOR

Placebo: 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.

Drug: Placebo

Interventions

PlaceboDRUG

Sterile saline encapsulated in hypromellose capsules and frozen.

Also known as: Encapsulated sterile saline
Placebo
encapsulated faecal microbiota filtrateDRUG

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

Also known as: FMFT
faecal microbiota filtrate
encapsulated faecal microbiotaDRUG

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

Also known as: FMT
faecal microbiota

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

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

Related Publications (1)

  • 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.

    PMID: 35193638DERIVED

MeSH Terms

Conditions

Colitis, UlcerativeInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Andreas Stallmach, Prof.

    Jena University Hospital

    STUDY DIRECTOR

Central Study Contacts

Andreas Stallmach, Prof.

CONTACT

+4936419324401andreas.stallmach@med.uni-jena.de

Kathleen Lange, MD

CONTACT

+4936419324641Kathleen.Lange@med.uni-jena.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
To address "concealment of allocation", the randomization will be done centrally and each patient who is randomized and who received one of the compared treatments is part of the full analysis set (ITT analysis set).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
coordinating investigator

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 18, 2019

Study Start

January 31, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(20)