Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3 Multicenter, RandomizeEd, Double Blind, Placebo COntrolled, Parallel Group Study to Evaluate the Safety, Tolerability, & Efficacy of SER-109 vs. Placebo to Reduce Recurrence of ClOstRidium Difficile Infection (CDI) in Adults
Brief Summary: Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II. The purpose of this study is to demonstrate the superiority of SER-109 vs placebo to reduce recurrence of CDI as determined by a toxin assay in adults up to 8 weeks after initiation of treatment.


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:

1. Adult outpatients (age ≥18 and \<75) referred to one of the study centers after suffering a third (or further) documented episode CDI and
2. who have failed to maintain CDI cure after standard therapy with oral vancomycin.

   * Previous treatment with at least one course of tapered/pulse dose vancomycin as per SHEA-IDSA C difficile treatment guidelines or -Inability to taper or stop vancomycin without developing diarrhea requiring anti-infective therapy. -

Exclusion Criteria:

* Patients who are aged 75 years or greater.
* Patients who are pregnant
* Patients who are nursing
* Patients who are incarcerated
* Patients with cognitive impairment or severe neuropsychiatric co morbidities who are incapable of giving their own informed consent
* Patients who are immunocompromised specifically:
* HIV infection (any CD4 count)
* AIDS-defining diagnosis or CD4\<200/mm3
* Inherited/primary immune disorders
* Immunodeficient or Immunosuppressed due to medical condition/medication:
* Current or recent (\<3 most) treatment with anti-neoplastic agent
* Current or recent (\<3 mos) treatment with any immunosuppressant medications (including but not limited to monoclonal antibodies to B and T cells, anti-TNF agents, glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine), calcineurin inhibitors (tacrolimus, cyclosporine), mycophenolate mofetil). Subjects who are otherwise immunocompetent and have discontinued any immunosuppressant medications 3 or more months prior to enrollment may be eligible to enroll.
* Patients with a history of severe (anaphylactic) food allergy
* Patients who have previously undergone FMT
* Patients who are unwilling or unable to undergo colonoscopy
* Patients with untreated, in-situ colorectal cancer
* Patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn"s disease or microscopic colitis) or irritable bowel syndrome
* Unable to comply with protocol requirements
* Patients who are American Society of Anesthesiologists (ASA) Physical Status classification IV and V
* Patients with acute illness or fever on the day of planned FMT will be excluded (not undergo randomization or treatment with FMT) with the option of including that subject at a future date.
C: Receiver

Inclusion Criteria:

* Age \> 18 years and \< 70 years
* Crohn's disease with colonic or ileo-colonic involvement
* Active disease at screening defined by a Harvey Bradshaw Index \>4
* Clinical remission (Harvey Bradshaw Index \<5) in the 3 weeks following corticosteroid onset
* Patient with health insurance
* Written consent obtained

Exclusion Criteria:

* Fistulizing disease
* Anoperineal or abdominal abscess
* Complication requiring surgical treatment
* Treatment with anti-TNFa (ongoing or stopped in the 1 month preceding randomization)
* Immunosuppressant treatment started or stopped in the 3 months preceding randomization
* Non-steroidal anti inflammatory drugs (NSAIDs) intake in the 4 weeks preceding randomization
* Antibiotics or antifungic treatment in the 4 weeks preceding colonoscopy
* Probiotics intake in the 4 weeks preceding colonoscopy
* Clostridium difficile infection in the 10 days preceding randomization
* contraindication to colonoscopy or anesthesia
* Pregnancy

Donor

Inclusion Criteria:

* Age \> 20 years and \< 50 years
* 27kg/m² \> BMI \> 17 kg/m²
* Regular bowel movement with usually one bowel movement in the morning
* Subject with health insurance
* Written consent obtained

Exclusion Criteria:

* Infection risk:

  * Known infection by human immunodeficiency virus (HIV), Human T Leukemia Virus (HTLV), Hepatitis B or C virus.
  * At risk behavior: Travel (in the preceding 3 months, excepting in Euro area, United Kingdom, Bulgaria, Poland, Romania, Croatia, Hungary, Republic Tcheque, Denmark, Norway, Sweden, Swiss, USA or Canada), at risk sexual activity (intercourse without protection with a new partner) in the preceding 6 months, blood transfusion, piercing or tattoo in the preceding 6 months residence of several years in intertropical area, abroad hospitalization more than 24 hours in the last 12 months (including patient and his immediate family).
  * Positive result at one of the screening tests for infectious disease. : HIV, HCV, HBV, HTLV, syphilis, Enteric viruses (Rotavirus, HEV, Adenovirus, Norovirus, Enterovirus, HAV, Poliovirus, Astrovirus, Aichi virus, Sapovirus), parasites in stool (Cyclospora, Isospora, Cryptosporidium, Microsporidium, Strongyloides stercoralis, Entamoeba histolitica, Giardia intestinalis, Dientamoeba fragilis), and in blood (Strongyloides stercoralis, Trichinella spiralis, Amoebiasis), pathogenic bacteria in stool (Clostridium difficile, Shigella, Campylobacter, Yersinia, Salmonella, Listeria monocytogenes, Vibrio cholerae/parahemolyticus, verotoxin-producing E. coli)
  * Anal lesions suggesting viral infection or positive test for HSV anal and/or multi-drug resistant bacteria (Enterobacteria producing extended spectrum betalactamase, Actinobacter baumanii, Vancomycin resistant enterococci and carbapenemase producing bacteria).
  * Positive test for multidrug resistant bacteria
  * If receiver is EBV negative, EBV positive donor will be excluded
  * If receiver is CMV negative, CMV positive donor will be excluded.
  * If receiver is negative for Toxoplasma gondii, positive donor for Toxoplasma gondii will be excluded
  * Known transmissible infectious disease
  * Infection (or possible infection) in the 7 days preceding screening
  * Risk factors for Creutzfeldt-Jakob disease
  * Personal history of Typhoid fever
* Gastrointestinal comorbidity

  * Personal history or first degree relative :

    * Inflammatory bowel disease
    * Coeliac disease
  * Personal history of irritable bowel syndrome, chronic constipation, chronic diarrhea
  * Personal history of gastrointestinal neoplasia or polyposis
  * First degree relative with gastrointestinal neoplasia or polyposis before 60 years old
  * Gastrointestinal infection in the 3 preceding months (defined by the occurrence of an acute diarrhea that last less than a week)
* Factors possibly affecting the composition of the microbiota:

  * Antibiotics or antifungic intake in the 3 preceding months before FT
  * Non-steroidal anti inflammatory drugs (NSAIDs) intake in the 4 weeks preceding FT
  * Specific diet (exclusion diet, vegetarian diet)
  * Pregnancy
  * Immunosuppressant intake (corticosteroids, calcineurin inhibitors, biologics, etc)
  * Anti neoplastic chemotherapy
  * Hemorrhoid disease
  * Personal history or first degree relative with inflammatory or autoimmune disease
* Other Factors :

  * Known chronic disease
  * Abnormality at initial biological check up: blood cells count, fasting, glycaemia, kidney function, liver tests, haemostasis, calprotectin
  * Long term curative therapy
  * Recent intake of food allergens related of receiver's known allergy
* between screening and FT :

  * At risk behavior (Travel, at risk sexual activity, blood transfusion, piercing tattoo, accidental blood exposure)
  * Anal lesions suggestive of viral infection or positivity for HSV in anal area
  * Infection or possible infection
  * Occurrence of gastro-intestinal symptoms
  * Medicine intake in the 48 hours preceding FT (except contraceptive)
  * In case of woman: menstruation in the 48 hours preceding FT
D: Main Inclusion Criteria:

1. Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject or their legally authorized representative must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment.
2. Male or female subject ≥ 18 years of age.
3. A qualifying episode of CDI as defined by:

   1. ≥ 3 unformed stools per day for 2 consecutive days
   2. A positive C. difficile stool toxin assay.
   3. The requirement of CDI SOC antibiotic therapy (defined as 10 to 21 days of treatment with vancomycin \[125 mg QID\] and/or fidaxomicin \[200 mg BID\]).
   4. An adequate clinical response following SOC antibiotic therapy, defined as (\<3 unformed stools in 24 hours) for 2 or more consecutive days before randomization.

Main Exclusion Criteria:

1. Female subjects who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
2. Known or suspected toxic megacolon and/or known small bowel ileus.
3. Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Note: nursing homes, rehabilitation, assisted living centers and acute care hospitals are acceptable.
4. Absolute neutrophil count of \<500 cells/ml\^3
5. Major gastrointestinal surgery (e.g. significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy), or any history of total colectomy or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e., restrictive procedures such as banding, are permitted).
6. History of active inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 3 months.
7. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with the study medical monitor).
8. Any history of fecal microbiota transplantation (FMT) within the previous 3 months.

Answer: D