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New treatment option for Ulcerative Colitis
Official title Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis
ClinicalTrials.gov ID: NCT03843385
What this study is testing
What is encapsulated faecal microbiota filtrate?
encapsulated faecal microbiota filtrate is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ulcerative colitis.
Also referred to as FMFT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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:
You likely can't join 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 \>...
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Jena, Thuringia, Germany
- Bamberg, Germany
- Berlin, Germany
- Dresden, Germany
- Erlangen, Germany
- Frankfurt, Germany
- Freiburg im Breisgau, Germany
- Fulda, Germany
- Halle, Germany
- Hamburg, Germany
- Kiel, Germany
- Leipzig, Germany
- Ludwigshafen, Germany
- Lüneburg, Germany
- Magdeburg, Germany
- München, Germany
- Ulm, Germany
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jena, Thuringia, Germany; Bamberg, Germany; Berlin, Germany; Dresden, Germany; Erlangen, Germany; Frankfurt, Germany and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.