Oral Vancomycin Followed by Fecal Transplant Versus Tapering Oral Vancomycin

• Status: Terminated
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Recurrent CDI is a growing problem with few treatment options that provide lasting effect. Fecal transplantation has been shown in several case series to be successful in controlling recurrent CDI. The current study is a non-blinded, randomized controlled trial comparing fecal transplantation with a 6 week taper of oral vancomycin for the treatment of refractory CDI. Approximately 146 patients will be enrolled over one year. Participants in the study will be followed for 120 days, and will be given the opportunity to cross over to the alternative intervention arm if a relapse in symptoms occurs. The primary outcome measure will be recurrence of toxin-confirmed CDI within 120 days of starting the intervention. Secondary outcomes include: early recurrence of symptoms within 14 days, relapse within 120 days (same strain of C. difficile), attributable mortality, hospitalization and serious adverse events.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Vancomycin

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.