Skyline Medical Center
POLICY AND PROCEDURE
TITLE: Fecal Bacteriotherapy
DEPARTMENT/SCOPE:
ORIGINATION DATE: 11/11
PAGE: 1 of 4
REFERENCE NUMBER: ADM.INF.057
REVISED DATE: REVIEWED DATE:
Approved By: _______________________ ___________________________
Administrative Officer Medical Director (if applicable)
PURPOSE:
To provide guidelines for bacteriotherapy treatment of resistant bowel infections by utilizing the fecal transplant technique.
POLICY:
1. Fecal bacteriotherapy (FBT), also known as fecal transfusion, fecal transplant, or human probiotic infusion (HPI), is a medical treatment for patients with pseudomembranous colitis caused by
Clostridium difficile. It may also be used to treat ulcerative colitis and irritable bowel syndrome.
2. Fecal bacteriotherapy consists of transferring stool from one person (donor) to another (patient) via enema, nasogastric, or gastrostomy tube infusion.
3. Documentation in the medical literature demonstrates that transplanting donor stool has resulted in successful resolution of the infection by repopulating normal intestinal flora in the bowel.
4. Diagnosis will be confirmed by Gastroenterologist or Infectious Disease Specialist.
5. Gastroenterologist or Infectious Disease Specialist wishing to use(FBT) will notify designated departments to schedule the testing/procedure, and discuss the process with donor and recipient for
Informed Consent.
PREPARING FOR PROCEDURE:
PHYSICIAN:
1. The ordering physician orders: Transplant route (NJ Tube, Colonoscopy, or retention enema); any variations from Order Sets (amounts of solution/testing/prepping); and follow-up in IR after NJ insertion if appropriate.
2. The ordering physician should document the presence of Clostridium difficile toxin in the patient’s stool (written or dictated history and physical), document traditional therapy without resolution of infection or with symptomatic relapse, and treatment history with traditional antibiotic medications.
3. The patient’s antibiotics are generally discontinued for 24-48 hours prior to transplant
4. Documentation should identify appropriate donor.
.
NURSING:
1. Verification of order
2. Notification of involved departments(Lab, Radiology, Endoscopy, Infection Prevention)
3. Patient Identification
4. Consent signatures
5. Verification of donor testing results
DONOR:
1. Ideally the stool transplant donors should be related to the recipient but not the spouse, significant other or a family household member. They should be healthy and have not received antimicrobial therapy in the last 2 months.
2. The donor should have normal bowel habits and be free of blood-borne or stool-borne pathogens.
3. The donor should have screening tests performed as an outpatient prior to the transplant. The following tests may be ordered: a. Acute Hepatitis Panel, HIV antibody, and CBC. b. Donor stool testing for Clostridium difficile toxin, Stool culture (C&S), Cryptosporidium stain, and
Stool for Ova and Parasites (O & P).

Donors will be instructed on reporting to Patient Registration/Outpatient Lab for testing.
 Acceptable donors will be given necessary supplies and instructed on specimen requirements, collection, and specimen return.
 Donors with positive test results in any of the testing identified will be excluded.

Skyline Medical Center
POLICY AND PROCEDURE
TITLE: Fecal Bacteriotherapy
REFERENCE NUMBER: ADM.INF.057 PAGE: 2 of4
RECIPIENT (PATIENT):
1. All recipients will have the following laboratory tests completed and reviewed by ordering physician prior to procedure: a. HIV antibody b. Hepatitis A antibody c. Hepatitis B surface antigen d. Hepatitis C antibody
2. Start Liquid diet the day prior to the scheduled FBT.
3. Cleanse patients’ bowel using 3-4 liter of Golytely, the day before FBT.
PROCEDURE
A. Order and Consent:
1. Verify written order by Physician for procedure
2. Obtain signed consent for Fecal Bacteriotherapy
3. Confirm results of donor testing as described above (if applicable).
4. Verify that involved departments (Lab, Endoscopy, and/or Interventional Diagnostics) are aware of time frame and flexibility required.
B. Stool specimen preparation for lower GI administration (colonoscopy or enema):
1.
Notify Lab of fecal transplant date; specimen is prepared in the Lab- on day of procedure obtain
250-300 gms (approx one cup) of fresh stool from donor as soon as possible prior to the transplantation procedure, never more than 4 hours prior. Using a blender, add stool to 250ml of
Normal Saline or Sterile Water. Mix until stool particles are dispersed throughout the liquid.
(Blender is cleansed and sent to Central Sterile after patient treatment completed)
2. Remove large particles by straining the stool/liquid mixture twice, utilizing strainer, into a specified container.
3. Transfer solution into labeled designated container(s) for transport to patient; refrigerate any unused stool for second infusion if initial transplant enema is not retained
4. Mixture should be administered within 2 hours of preparation. No more than 6 hours should elapse between stool specimen collection and fecal administration. If the 1st enema is not retained at least 1 hour, contact lab for stored stool.
C. Lower GI administration:
1. Verify correct patient
2. Verify signed consent
3. Explain procedure to the patient.
4. Staff must wear gown, gloves, mask, and eye protection.
5. Instillation of solution procedure may be accomplished via several methods.

Endoscopy Lab

Standard Enema Set:
 Place patient in left lateral decubitus position.
 Lubricate the catheter tip and insert into rectum.
 Connect enema bag and instill the solution into patient.
 Hold the tube in place throughout the procedure.
 Adjust flow as tolerated by patient; slower rates will promote solution retention.
 Repeat enema with fresh stool next day (Day 2) if ordered

Fecal Management System (ActiFlo)
 Lubricate the rectal catheter with retention ring and insert into the rectum.
 Gently inflate catheter ring and gently pull the catheter back against the patient’s internal anal sphincter to seal.
 Connect enema bag and instill the solution into recipient. 2 oz Catheter Tip syringes may be used to instill solution.

Skyline Medical Center
POLICY AND PROCEDURE
TITLE: Fecal Bacteriotherapy
REFERENCE NUMBER: ADM.INF.057 PAGE: 3 of4
 Adjust flow as tolerated by patient; slower rates will promote solution retention.
Once solution instilled, patient should retain the solution. Retention of one hour is adequate, longer than two hours is unnecessary. If the solution is expelled in less than one hour, the procedure may be immediately repeated. Allow solution to drain into containment bag after one-two hours has passed.
 Documentation should include: a. Enema or rectal tube used b. Volume infused c. Amount of time patient able to hold. d. If rectal tube used, document deflating of ring. e. How patient tolerated the procedure.
D. Stool Preparation for Upper GI Administration:
1. Notify Lab /Diagnostics that a fecal transplant is planned.
2. On the day of the procedure, obtain 100 g (approx 1/3 to 1/2 cup) of donor stool
3. Specimen is prepared in the Lab. after the NJ tube is placed and has been repositioned by
Radiology
4. Using a blender, add stool to 100 ml (or necessary amount to facilitate installation) of Normal
Saline or Sterile water. Mix until stool particles are dispersed throughout the solution.
5. Remove large particles by straining the stool/saline mixture twice, utilizing a strainer, into a graduate container.
6. Transfer solution into catheter tip syringes for transport to patient; label with date, time, and patient/donor names.
E. Upper GI Tract Transplant Administration
1. Verify correct patient.
2. Explain procedure to the patient.
3. Insert NJ (endoscopic lab)/Dobhoff tube into stomach; if Dobhoff Tube is used, have patient transported to radiology for ‘positioning’ of Dobhoff into proximal jejunum or distal duodenum. If
NJ tube is used, it is inserted into Jejunum through endoscope.
4. Once NJ tube has been repositioned, notify Lab to proceed with specimen preparation
5. Don gown, gloves, mask, and eye protection.
6. Using a syringe administer the freshly mixed stool via NJ/ Dobhoff tube. After stool installation, flush with 50ml of normal saline. (DO NOT REMOVE NJ/DOBHOFF TUBE).
7. Repeat stool infusion procedure next day as above.
8. Do not remove NJ/Dobhoff tube until ordered by physician
F. Documentation under Notes should include: a. Size NJ /Dobhoff tube used b. Volume infused c. How patient tolerated the procedure.
REFERENCES
Borody, T.J., Warren, E.F., Leis, S. m., Surace, R., Ashman, O., & Siarakas, S. (2008). Bacteriotherapy
Using Fecal Flora: Toying with Human Motions. Journal of Clinical Gastroenterology , 38(6), 475-483.
You, D.M., Franzos, M.A. & Holman, R.P. (2008). Successful Treatment of Fulminant Clostridium Difficile
Infection with Fecal Bacteriotherapy. Annals of Internal Medicine, 148, 632-3.
Silverman, M.S., Davis, I., Pillai, D. (2010). Success of Self-Administered Home Fecal Transplantation for
Chronic Clostridium Difficile Infection. Journal of Clinical Gastroenterology & Hepatology , 2010;8:471-
473.

Skyline Medical Center
POLICY AND PROCEDURE
TITLE: Fecal Bacteriotherapy
REFERENCE NUMBER: ADM.INF.057 PAGE: 4 of4
Cohen, S.H. et al; (2010) . Clinical Practice Guidelines for Clostridium Difficile Infection in Adults: SHEA &
IDSA Update. Infection Control and Hospital Epidemiology , May 2010, Vol. 31, No. 5.