Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Standardized Fecal Microbiota Transplantation for Moderate to Severe Crohn's Diseases
Brief Summary: The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using fecal microbiota transplantation (FMT) for Ulcerative Colitis (UC), Crohn's diseases (CD), irritable bowel syndrome (IBS) and constipation have also met with some success. However, the results on CD is very limited. This marks the initial step in exploring the potential efficacy of fecal bacteriotherapy for CD. The investigators aim to evaluate the effectiveness, durability, and safety of FMT in a cohort of at least 500 patients with CD over a ten-year period


Options:
A: Inclusion Criteria:

* Patients with history of mild to moderate Ulcerative Colitis confirmed by endoscopy and pathology.
* Total Mayo score 4-9, endoscopic subscore ≥1; patients who have not had endoscopic evaluation within one year of enrollment will have flexible sigmoidoscopy for evaluation.
* Age 18 - 64 and deemed otherwise healthy at the discretion of the investigator.
* Concurrent therapies with mesalamine (stable x 4 weeks), immunomodulators (stable x 3 months), and biologic agents (stable x 3 months) will be allowed to continue during study.
* If patient is on prednisone, the dose must be ≤ 10mg/day at the time of treatment and will be weaned by 2.5mg/week during the study period.

Exclusion Criteria:

* Severe or refractory UC defined as Mayo score ≥10, endoscopic disease activity score 3
* Untreated enteric infection (positive stool test for any of the following: Clostridium difficile, Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic E. coli or other enteric infection at the discretion of the investigator.
* History of colectomy
* Disease limited to distal proctitis
* Patients taking probiotics within 6 weeks of planned FMT therapy.
* Severe immunodeficiency, inherited or acquired (e.g. HIV, chemotherapy or radiation therapy)
* Patients with the following laboratory abnormalities: absolute neutrophil count (ANC) \< 1000 / µl, platelets \<50 x 10\^9 /L,, hemoglobin \<6.5 g/dL..
* History of anaphylaxis (severe allergic reaction) to food allergens (e.g. tree nuts, shellfish)
* Dysphagia (oropharyngeal, esophageal, functional, neuromuscular)
* History of recurrent aspiration episodes
* Documented severe gastroparesis
* Active intestinal obstruction
* Patients with renal insufficiency (GFR \< 50ml/min)
* Allergy to the following generally regarded as safe ingredients (GRAS): glycerol, acid resistant HPMC, gellan gum, cocoa butter, titanium dioxide
* Adverse event attributable to any previous FMT
* Allergy/intolerance to proton pump inhibitor therapy
* Allergy/intolerance to vancomycin, metronidazole, or neomycin.
* Non-steroidal inflammatory medications (NSAIDs) as long-term treatment, defined as use for at least 4 days a week each month.
* Cholestyramine use
* Any condition in which the investigator thinks the FMT treatment may pose a health risk (e.g. severely immunocompromised)
* Simultaneous participation in another interventional clinical trial
* Patients who are pregnant, breast feeding or planning pregnancy during study trial period.
* During the trial period until one week after the trial end: Non-use of appropriate contraceptives in females of childbearing potential (e.g. condoms, intrauterine device (IUD), hormonal contraception, or other means considered adequate by the responsible investigator) or in males with a child-fathering potential (condoms, or other means considered adequate by the responsible investigator during treatment) or well-founded doubt about the patient's cooperation
* Patients with any other significant medical condition that could confound or interfere with evaluation of safety, tolerability or prevent compliance with the study protocol at the discretion of the investigator
* Life expectancy \<6 months
B: Inclusion Criteria:

* Patients aged 18 or over with active UC defined as a Mayo score (13) more than 3 with an endoscopic score more than 0 will be eligible for the study
* Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF therapy (e.g. infliximab) will be permitted if taken at stable dose for more than or equal to 12 weeks prior to randomization.

Exclusion Criteria:

* Subjects will be excluded if they are participating in another clinical trial, are unable to give informed consent, have severe comorbid medical illness, have concomitant Clostridium difficile infection or have severe UC requiring hospitalization.
C: Inclusion Criteria:

Clinical diagnosis of Crohn's disease, with the diagnosis remaining unchanged after at least three months of follow-up.

Willingness to undergo FMT (Fecal Microbiota Transplantation).

Exclusion Criteria:

Presence of serious conditions that made them unsuitable for inclusion (e.g., malignant neoplasms, cardiopulmonary failure, serious liver or kidney disease).
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