Please select the eligibility criteria that correspond to the clinical trial below.
Title: Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis
Brief Summary: This is a prospective unblinded, randomized trial for the use of Fecal Microbiota Transplantation (FMT) for the treatment of Ulcerative Colitis (UC), in combination with or without antibiotic pretreatment.


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:

1. Patients aged 18 or over
2. Active UC defined as a Mayo score \> 3
3. A Mayo endoscopic score \> 0

Exclusion Criteria:

1. Participating in another clinical trial
2. Unable to give informed consent
3. Severe co-morbid medical illness
4. Concomitant Clostridium difficile infection
5. Severe UC requiring hospitalization.
6. Increase in medical therapy for UC in the last 12 weeks. Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF alpha therapy (e.g. infliximab) will be permitted if taken at stable dose for ≥12 weeks prior to randomization. Relapse on a stable dose (same dose for at least 2 weeks) or a tapering dose of steroids will also be permitted provided the dose of steroid is not increased again. Stable intake of probiotic therapy also permitted.
7. Antibiotic therapy in the last 30 days.
8. Pregnant women.
C: 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
D: Participant Inclusion Criteria:

1. Children ages \>7 and ≤21 years of age with established diagnosis of Inflammatory Bowel Disease (IBD) colitis (patient with ulcerative colitis (UC) or patients with crohn's disease (CD) with colonic involvement only)
2. Have clinical disease (mild to moderate disease: 10≤ Pediatric Ulcerative Colitis Activity Index (PUCAI) \<65)
3. Have stable disease activity and therapy for two months prior to Gut Microbial Transplantation (GMT) procedure.

Participant Exclusion Criteria:

1. Fulminant colitis
2. Indication or scheduled for surgery
3. Pregnancy
4. Use of probiotic supplements during the study period (subjects who have stopped use of probiotic supplements will be eligible as long as they stop taking it 2 weeks prior to Day 1 of GMT)
5. anemia (hemoglobin \< 6.0 g/dL) in last one month
6. Graft versus host disease (GVHD)
7. Severely immunocompromised - defined as

   1. History of opportunistic infection (tuberculosis, Pneumocystis jirovecii or systemic fungal infections) in last one year or
   2. Neutropenia: Absolute neutrophil count (ANC) \<500
8. Major intra-abdominal surgery within 90 days prior to Day 1 of GMT
9. Administration of any investigational drug within 30 days prior to Day 1 of GMT.
10. Have received infliximab or other tumor necrosis factor (TNF) inhibitors within 2 months prior to Day 1 of GMT or are expected to receive such therapy within 1 month post final GMT.

Donor Inclusion Criteria

1. Based on patient's and parents'/guardian's decision
2. Will be chosen from immediate adult (≥18 years) family members or close friends
3. Should have negative or normal results on screening tests (as explained in donor exclusion criteria below)

Donor Exclusion Criteria (adopted from guidelines provided by American Association of Blood Bank Donor History Questionnaire and American Gastroenterological Association)

1. Positive or abnormal screening test to include:

   1. Hepatitis A Immunoglobulin M (IgM) antibody
   2. Hepatitis B antibody panel suggestive of infection (HBc IgM, HBs Ag, HBs Ab)
   3. Hepatitis C antibody Level
   4. Cytomegalovirus (CMV) IgM antibody
   5. Ebstein Barr Virus (EBV) viral capsid antigen (VCA) IgM antibody
   6. Syphilis Immunoglobulin G (IgG) Ab Screen
   7. Human Immune Deficiency Virus (HIV) I \& II enzyme-linked immunosorbent assay (ELISA) screen
   8. Stool i) Fungal smear ii) Stool cultures to exclude Salmonella, Shigella, Escherichia Coli, Campylobacter, Yersinia, Vibrio, Listeria iii) Clostridium difficile toxin assay iv) Ova and parasite screen for Giardia and Cryptosporidium
2. History of metabolic syndrome or gastric bypass surgery
3. History of GI conditions: IBD, irritable bowel syndrome, chronic abdominal pain, GI Malignancy, blood in stool or diarrhea in the last 4 weeks before enrollment
4. Antibiotic or probiotic use within 3 months before enrollment and for the duration of the donation
5. Positive response on screening questionnaire to any of the following:

   1. History of active malignancy or any cancer within the last 5 years (excluding basal cell carcinoma of the skin)
   2. Family history of Creutzfeld-Jacob disease
   3. Corneal or dural transplant
   4. History of high risk sexual behavior (e.g. sexual contact with HIV/acquired immune deficiency syndrome (AIDS) positive, hepatitis positive partner, men who have sex with men, sex for drugs or money)
   5. History of signs of sexually transmitted infections such as genital ulcerations, anogenital herpes, anogenital warts, cancroids or syphilitic lesions
   6. Use of illicit drugs
   7. Travel within the last 6 months to areas of the world where diarrheal illnesses are endemic
   8. History or signs of immunosuppression i) History of any immunosuppressant medication(s) within the last 6 months or history of opportunistic infection(s) in past 1 year ii) Signs of immunosuppression such as:

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   1. Oral thrush
   2. Disseminated lymphadenopathy

Answer: A