Please select the eligibility criteria that correspond to the clinical trial below.
Title: Two-arm, Interventional, Prospective, Open-label, Multi-center Trial to Evaluate the Safety & Effectiveness of FMT for Treatment of Adult Patients With Primary or Recurrent CDI, Using a Novel, Standardized Microbiota Transplantation System
Brief Summary: This study is a two-arm, interventional, prospective, open-label, multi-center clinical trial with randomized and non-randomized study groups to evaluate the safety and effectiveness of faecal microbiota transplantation (FMT) for the treatment of adult patients suffering from primary or recurrent Clostridium difficile infection (CDI), using a novel, standardized microbiota transplantation system.


Options:
A: Inclusion Criteria:

* Laboratory or pathology-confirmed diagnosis of recurrent C. difficile infection (CDI) with symptoms within the previous 60 days. Recurrent CDI is defined as:

  * \>/=2 episodes of CDI. Eligible patients must have had at least one treatment course with oral vancomycin (minimum 10 days of 500 mg total daily oral vancomycin).

Symptoms of CDI include:

* Diarrhea (see below) OR
* Abdominal pain AND abdominal distension/bloating AND fever, systemic illness with no other reason for these symptoms

Diarrhea will be self-reported and is defined as:

* at least 6 watery feces in 36 hours OR
* 3 unformed feces in 24 hours for minimum 2 days OR
* 8 unformed feces over 48 hours

  * Age 18 years or older
  * Signed informed consent
  * Able to travel to clinic for follow-up visit and/or adhere to study procedures
  * Agrees to abstain from taking probiotic supplementations for medicinal reasons for the duration of the study and follow-up period. To clarify, dietary intake is acceptable (e.g. non-supplemented yogurt).

Exclusion Criteria:

* Planned participation in another clinical trial
* Patients with conditions such as neutropenia, graft versus host disease or severe immunocompromise, in whom enemas are contraindicated
* More than one episode of CDI that has been severe or rapid in onset, resulting in:

  * intensive care unit admission
  * Evidence of active, severe colitis (ie. ongoing diarrhea not responsive to oral vancomycin; hemorrhagic colitis) such that an enema is contraindicated (note that such patients may be eligible once their colitis is under control)
  * Unable to tolerate fecal transplantation procedure for any other reason
  * Hypersensitivity or intolerance to oral vancomycin
  * Patients with underlying chronic gastrointestinal diseases that cause diarrhea, such as:
  * Inflammatory bowel disease
  * Short gut syndrome
  * Severe motility disorders
  * Severe diverticular disease
  * Other chronic diarrhea NYD
  * Unable to record frequency of bowel movements
  * Receiving an investigational medication
  * Planned therapy in the next 120 days that may cause diarrhea (example: chemotherapy)
  * Planned surgery requiring perioperative antibiotics within 120 days
  * Pregnancy
  * Requires the regular use of medications that affect bowel motility before onset of CDI (example: metoclopramide, narcotics, loperamide)
  * Serious bleeding disorder, anticoagulant use that cannot be stopped temporarily for procedure (in consultation with prescribing physician) or serious platelet disorder (platelet counts below 50).
  * Any condition that, in the opinion of the investigator, would pose a health risk to the subject.
B: Inclusion Criteria for patients:

* Patients with IBS-D according to Roma 3 criteria

Exclusion Criteria for patients:

* Immunomodulating medication
* Nocturnal abdominal pain
* Constant abdominal pain
* Alarm symptoms like rectal bleeding, weight loss, nightsweats
* Symptomatic heart/vascular/lung disease
* Renal failure
* Known food allergy
* Microscopic/collagenous colitis
* non-compliant
* BMI \<18

Inclusion criteria for donors:

* healthy volunteers

Exclusion criteria for donors

* Tattoos, imprisoning or piercing last 3 months
* Any history of chronic diarrhoea, constipation, inflammatory bowel disease, irritable bowel disease, colorectal polyps or cancer, immunosuppression, morbid obesity, metabolic syndrome, atopica, or fatigue
* positive test for hepatitis B, C, HIV, treponema pallidum
* sexual high risk habits
* antibiotic treatment in the past 3 months
C: Patient inclusion criteria

1. Age 18 years or older.
2. Able to provide informed consent.
3. Laboratory or pathology: confirmed diagnosis of recurrent CDI with symptoms (defined below) within the previous 180 days.
4. ≥ 2 episodes of CDI within 6 months and/or ongoing symptoms consistent with CDI despite treatment with oral vancomycin at a dose of at least 125 mg 4 times daily for at least 5 days.

Symptoms of CDI, diarrhea deﬁned as: 3 or more unformed bowel movements in 24 hours for a minimum of 2 days with no other causes for diarrhea. Subjects will be required to have laboratory or pathology-confirmed diagnosis of recurrent C. difficile infection where recurrence is deﬁned as return of diarrhea and positive stool test after a period of symptom resolution within 8 weeks of the first episode and has received at least a 10-day course of standard antibiotic therapy.

Patient exclusion criteria

1. Planned or actively participating in another clinical trial.
2. Patients with neutropenia with absolute neutrophil count \<0.5 x 109/L
3. Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray
4. Peripheral white blood cell count \> 30.0 x 10E9/L AND temperature \> 38.0 oC
5. Active gastroenteritis due to Salmonella, Shigella, E. coli 0157H7, Yersinia or Campylobacter.
6. Presence of colostomy
7. Unable to tolerate HBT or enema for any reason.
8. Requiring systemic antibiotic therapy for more than 7 days.
9. Actively taking Saccharomyces boulardii
10. Severe underlying disease such that the patient is not expected to survive for at least 30 days.
11. Any condition that, in the opinion of the investigator, that the treatment may pose a health risk to the subject.

Donor inclusion

1. Able to provide and sign informed consent.
2. Able to complete and sign the donor questionnaire
3. Able to adhere to fecal transplantation stool collection standard operating procedure.

Donor exclusion

1. Tested positive for any of the following: Human Immunodeficiency virus (HIV) 1/2, hepatitis IgM, hepatitis B (HBsAg), hepatitis C antibody, syphilis, human T- lymphotrophic virus (HTLV) 1/II and vancomycin resistant Enterococcus (VRE), methicillin resistant S. aureus (MRSA), Salmonella, Shigella, E.coli O157 H7, Yersinia and Campylobacter.
2. Detection of ova, parasites, C. difficile toxin, norovirus, adenovirus, rotavirus on stool examination
3. History of any type of active cancer or autoimmune disease
4. History of risk factors for acquisition of HIV, syphilis, Hepatitis B, Hepatitis C, prion or any neurological disease as determined by the donor questionnaire, appendix B.
5. History of gastrointestinal comorbidities, e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation or diarrhea
6. Receipt of blood transfusion from a country other than Canada in preceding 6 months
7. Antibiotic use or any systemic immunosuppressive agents in the 3 months prior to stool donation
8. Receipt of any type of live vaccine within 3 months prior to stool donation
9. Ingestion of nut or shell fish 3 days preceding donation if the recipient has known allergies to these food.
10. Any current or previous medical or psychosocial condition or behaviours which in the opinion of the investigator may pose risk to the recipients or the donor
D: Inclusion Criteria:

* Group "R":- recurrent CDI;- positive stool toxin test within 72 hours before enrolment
* Group "F":- first (initial) episode of CDI;- enrolled patient falls in at least one of the following categories:high risk of recurrence or high risk of developing severe CDI or severe or life-threatening CDI;- patient requires hospitalization or CDI occurs during a hospital stay;- persisting symptoms despite least 72 hours of adequate antibiotic treatment;-positive stool CD toxin test obtained within 72 hours before screening;- in all cases, primary consideration must be given to the severity and pace of the patient's CDI when deciding whether early use of FMT is appropriate to prevent further clinical deterioration.

Exclusion Criteria:

* absence of either patient's or its legally authorized representative's informed consent
* inability or unwillingness to comply with protocol requirements
* severe co-morbidities, terminal underlying disease with a life expectancy of less than 90 days
* pregnancy or breastfeeding
* active gastroenteritis caused by microorganisms other than CD
* underlying chronic gastrointestinal disease that causes diarrhoea such as autonomic diabetic neuropathy, short bowel syndrome, faecal incontinence, active inflammatory bowel disease
* alimentary or over-the-counter drog allergy with previous anaphylactic reaction
* absolute contraindication to FMT

Answer: D