Please select the eligibility criteria that correspond to the clinical trial below.
Title: Longterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitis
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.


Options:
A: Inclusion Criteria:

* Men or women 18-75 years of age.
* Established diagnosis of ulcerative colitis (UC) with known involvement of the left colon
* Mild to moderate disease defined as endoscopic evidence of disease with Mayo endoscopic sub-score 1 or 2 and total MAYO score ranging from 4-10. (The Mayo score ranges from 0 to 12, with higher scores indicating more severe disease. This score can be used for both initial evaluation and monitoring treatment response).
* Patients may be on any class of IBD-related medication (excluding steroids)
* Patients must be on stable medication regimen for at least 6 weeks prior to enrollment.
* Ability to understand and willingness to sign informed consent document

Exclusion Criteria:

* Patient who are asymptomatic
* Patients with severe, refractory disease (defined as Mayo scores of \> 10, or endoscopic disease activity score of \> 3) or patients with any other significant condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety, tolerability of the investigational treatment or prevent compliance with the study protocol
* Prior colectomy
* Positive stool test for any of the following: Clostridium difficile by PCR, Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic E. coli by standard stool culture.
* Use of the steroid medications (any formulation) in the prior 6 weeks to enrollment
* Systemic antibiotic use within prior 6 weeks to enrollment
* Regular probiotic supplement use within prior 48 hours to enrollment
* Pregnancy or breastfeeding
* Severe immunodeficiency, inherited or acquired (e.g. HIV, chemotherapy, or radiation therapy)
* History of anaphylaxis (severe allergic reaction)
* Documented allergy to fluoroquinolones, metronidazole
* Life expectancy less than 12 months
* Age less than 18 or greater than 75 years of age
* History of esophageal or gastric motility disorders.
B: Inclusion Criteria:

for UC

1. Patients should be in the age range of 18 - 70 years;
2. Patients should have clinical, imaging, endoscopic and histological diagnosis of UC;
3. Patients should have a UCDAI score of more than 2 and less than 10 or stage at S1/S2 in Montreal Rank at enrollment;
4. Patients receiving a stable dose of concomitant medication (aminosalicylates, oral corticosteroids) for at least 4 weeks are eligible;
5. Patients are capable of providing written informed consent and obtained at the time of enrollment;
6. Patients are willing to adhere to the study visit schedule and other protocol requirements.

for CD:

1. Patients should be in the age range of 18 - 40 years;
2. Patients should have clinical, imaging, endoscopic and histological diagnosis of early CD\*;
3. Patients should have a CDAI score of more than 150 and less than 400and have a C-reactive protein (CRP) level of more than10mg/L at enrollment;
4. Patients receiving a stable dose of concomitant medication (aminosalicylates, oral corticosteroids) for at least 4 weeks are eligible;
5. Patients are capable of providing written informed consent and obtained at the time of enrollment;
6. Patients are willing to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

1. Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period
2. Patients may confuse the findings or there exist any other additional risk history
3. Patients with end-stage disease or is expected likely to die during the study
4. Patients are participating in other clinical trials or participated within 3 months prior to transplantation
5. Outbreaks, infectious (viruses, bacteria, parasites, or other microorganisms) colitis, scheduled for abdominal surgery,take probiotics / prebiotics / synbiotics / antibiotic / PPI (past 1 month) orally, severe anemia (Hbg \<6g/dl), heart cerebrovascular accident, bypass, stent implantation surgery in the last 6 months, coagulation disorders, immune suppression status (defined as: immunosuppressive drugs, a history of opportunistic infections within one year recurrent ,oral ulcers, multiple lymphadenopathy, neutropenia, etc.), major abdominal transplant surgery in the last 3 months, have took TNF-α monoclonal antibody 2 month before transplantation or planned to take within one month after transplantation, a history of megacolon -
C: 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)
D: Inclusion Criteria:

* 3yo to 17yo at start of trial
* Followed at a participating clinical trial site: a) McMaster Children's Hospital, b) Children's Hospital at London Health Sciences Centre, c) Centre Hospitalier Universitaire Sainte-Justine
* Ulcerative colitis (UC) or Inflammatory bowel disease unclassified (IBD-U)
* Evidence of active clinical, biological, or mucosal disease
* Ongoing treatment is acceptable provided the patient has had no significant changes to medications, or medication dose for at least 4 weeks prior to starting the trial

Exclusion Criteria:

* Active participation in another therapeutic trial
* Unable to give informed consent, or assent
* Active Clostridium difficile infection
* Significant change in medication type, or medication dose within the preceding 4 weeks prior to starting the trial
* Starting new treatments, or having a significant change in medication dosing during the trial
* Significant, consecutive rise in PUCAI score during the trial
* Hospitalization during trial

Answer: C