Please select the eligibility criteria that correspond to the clinical trial below.
Title: Impact of Fecal transPlantAtion on MiCrobotia and hosT in Crohn's Disease
Brief Summary: Crohn's disease is a chronic and relapsing inflammatory bowel disease. Many data show that the intestinal flora is involved in the disease and it has been show that patients with Crohn's disease exhibit an abnormal fecal flora that might play a role in inflammation. The purpose of this study is to determine the effect of the fecal flora transplantation on Crohn's disease.


Options:
A: 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
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:

* 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
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