Efficacy and Safety of Fecal Microbiota Transplantation for Severe Clostridium Difficile Associated Colitis

Screening and Consent - Index cases:

1. Hospitalized patient with the diagnosis of severe CDAD
2. At screening visit the study investigator(s) will explain the study in detail, answer any questions the candidate may have, and give the candidate a consent form to read and sign.
3. After signing the consent form, the candidate subject will be asked to provide a complete medical history and undergo a physical examination.
4. Blood will be drawn for a complete blood count (CBC) and bacterial culture
5. Stool will be collected and archived for use for further analysis as deemed necessary by the principal investigator. All analyses will be performed in an anonymous coded method, without any disclosure of the patient identifiers.

Screening and Consent - Donors:

1. Identified by recipients, generally an intimate partner or adult family member
2. Willing to donate stool
3. Exclusion criteria (per questionnaire):
4. Had taken antibiotics within 90 days of the planned procedure
5. Fever, diarrhea, vomiting, or any other symptoms of infection, which occurred within the two weeks prior to the day of the procedure.
6. Known exposure to HIV or viral hepatitis (within the previous 12 months)
7. High-risk sexual behaviors (examples: sexual contact with anyone with HIV/AIDS or hepatitis, men who have sex with men, sex for drugs or money)
8. Use of illicit drugs
9. Tattoo or body piercing within 6 months
10. Incarceration within previous 12 months
11. Known current communicable disease
12. Risk factors for variant Creutzfeldt-Jakob disease
13. Gastrointestinal co-morbidities
14. History of inflammatory bowel disease
15. History of irritable bowel syndrome, idiopathic chronic constipation, or chronic diarrhea
16. History of gastrointestinal malignancy
17. Recent ingestion of a potential allergen (eg, nuts) where recipient has a known allergy to this agent
18. Systemic autoimmunity, for example, multiple sclerosis, connective tissue disease
19. Exclusion criteria (per laboratory assays):
20. Positive HIV, hepatitis C virus, hepatitis B virus, Syphilis antibodies
21. Stool culture positive for the enteropathogenic bacteria Salmonella, Shigella, or Campylobacter
22. Stool stain positive for Ova and Parasites
23. Stool positive for Giardia- and Entamoeba histolytica-specific antigens
24. Stool positive for C. difficile toxins

Fecal Microbiota Transplantation Protocol Donor

1. Provide informed consent (laxative administration)
2. Report symptoms of infection, which occur between screening and the day of the procedure
3. Take a single dose of osmotic laxative (one tablet of "Laxadin") on the evening before the procedure
4. Provide fresh stool, at least 50 grams

Recipient 1. Provide informed consent

Fecal solution preparation

1. Universal precautions (gown, gloves, eye protection) during stool processing
2. Fresh (<6 h) donor stool specimen
3. About 50 grams of donor stool, diluted and shaken vigorously in sterile Saline 0.9% to homogeneity.
4. Filter stool through gauze if necessary to remove large debris
5. Stool suspension drawn up into 50 mL slip-tip syringes

Procedure

1. Informed consent for colonoscopy obtained including the additional theoretical risk of infection related to fecal transfusion
2. Document that examination of the colon is not adequate for cancer screening purposes (stool infusion interferes with visualization)
3. Colonoscopy performed aiming to reach the cecum with or without decompression without bowel inflation. If the cecum is not reachable the injection will be performed at the most distal site.
4. No biopsies taken
5. Upon withdrawal, injection of the fecal suspension via the biopsy channel of a colonoscope, majority into the right colon. Deliver between 300-500 ml.

Post procedure

1. Patient encouraged to retain stool (if possible) for 4 hours

Clinical and laboratory follow up

1. A blood culture will be drawn immediately following the procedure
2. Subjects will be followed during hospitalization and after discharge for at least 30 days. Data on symptoms of CDAD, on-going medical history review, physical examination, and laboratory tests as described in Table 1 will be collected.
3. Safety will be assessed by monitoring the subjects for adverse events.