Please select the eligibility criteria that correspond to the clinical trial below.
Title: Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety
Brief Summary: The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting a randomised controlled trial


Options:
A: Inclusion Criteria:

* Patients with recurrent or relapsing CDI defined as EITHER(13):

  * At least three episodes of mild-to-moderate CDI and failure of a 6-8 week taper with vancomycin with or without an alternative antibiotic (e.g. rifaximin, nitazoxanide).
  * At least two episodes of severe CDI resulting in hospitalization and associated with significant morbidity.
* Willingness to accept risk of unrelated donor stool
* Willingness to be randomized to NGT vs. colonoscopic delivery.
* Able to consent for self, or parental assent/child assent as age appropriate.

Exclusion Criteria:

* Anatomic contraindication to NGT
* Delayed gastric emptying syndrome
* Known chronic aspiration
* Contraindication to colonoscopy (ASA 4 or more)
* High risk of bacterial translocation (Immunosuppression, cirrhosis etc)
* Pregnant or breastfeeding women
* Acute unrelated infection or comorbid illness exaccerbation
B: Inclusion Criteria:

* Ulcerative colitis \>3 months duration
* Active mild-moderate ulcerative colitis (Mayo 4-10)
* Ulcerative colitis of any extent except isolated proctitis \< 5cm
* Live within driving distance of clinical site (to attend multiple study visits)

Exclusion Criteria:

* Pregnancy
* Active gastrointestinal infection
* Other gastrointestinal disease / comorbidities
* Prior colonic surgery
* Recent antibiotic or probiotic use
* Prednisone \> 20mg
* Monoclonal antibody immunosuppressive therapy
C: Inclusion Criteria:

* Age ≥ 18
* Ability to give informed consent
* Established ulcerative colitis with known involvement of the left colon according to the Lennard-Jones criteria
* SCCAI of 4 \> \< 11
* Endoscopic Mayo score of \> 1
* Stable dose of thiopurines in preceding 8 weeks
* Stable dose of corticosteroids and 5-ASA in preceding 2 weeks

Exclusion Criteria:

* Condition leading to profound immunosuppression
* Anti-TNF treatment in preceding 2 months
* Cyclosporine treatment in preceding 4 weeks
* Use of Methotrexate in preceding 2 months
* Prednisolone dose \> 10 mg
* Life expectancy \< 12 months
* Use of systemic antibiotics in preceding 6 weeks
* Use of probiotic treatment in preceding 6 weeks
* Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic e coli)
* Positive faecal PCR-test (positive PCR means: \> 1 of the following viruses is present) for: Rotavirus, Norovirus, Enterovirus, Parechovirus Sapovirus, Adenovirus 40/41/52. Astrovirus.
* Pregnancy or women who give breastfeeding
* Vasopressive medication, icu stay
D: 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)

Answer: B