Oral Vancomycin Followed by Fecal Transplant Versus Tapering Oral Vancomycin
Recurrent Clostridium Difficile Infection, Laboratory Confirmed Clostridium Difficile Infection
About this trial
This is an interventional treatment trial for Recurrent Clostridium Difficile Infection focused on measuring Clostridium difficile, Fecal Transplant, Recurrent Diarrhea, Abdominal distension/bloating, Fever
Eligibility Criteria
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.
Sites / Locations
- University Health Network
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Fecal Transplant
Oral Vancomycin Taper
2 weeks of oral vancomycin pre-treatment followed by single dose fecal transplant administered by rectal enema. Fecal transplant (slurry) consists of 50 grams healthy donor stool blended in 500ml of Normal Saline.
2 weeks of oral vancomycin pre-treatment followed by 6-week taper of oral vancomycin