Clinical trial NCT02686645: Fecal Microbiota Therapy for Recurrent Clostridium Difficile Infection
Official title: Fecal Microbiota Therapy for Recurrent Clostridium Difficile Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Clostridium Difficile Infection
Keywords: Fecal Microbiota Transplantation
Lead sponsor: Queen Elizabeth II Health Sciences Centre
Sponsor class: OTHER
First posted: 2016-02-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Interventional, single arm, single-centre trial to evaluate the effectiveness and safety of fecal microbiota therapy (FMT) in the investigators population.

Detailed description: This is a study of the effects of FMT for the treatment of patients with recurrent Clostridium difficile infection (CDI). The investigators plan to enrol approximately 5-10 patients per year over the next 5 years to a maximum of 50 patients. Patients with recurrent CDI referred to the designated Gastrointestinal (GI) or Infectious Diseases (ID) services will be screened for inclusion and exclusion by the primary investigator (PI), sub investigators and/or designated study personnel.

Those patients meeting the criteria will be offered FMT and will be the recipient. An informed consent will be obtained from both the recipient and the donor prior to proceeding with the study protocol. Demographic information as well as details of the medical history and results of standard laboratory tests will be collected on the recipients and donors.

The donor preferably should be \< 60 years old to maximize the fecal microbiota. As this does involve biological samples there is a theoretical risk of transmission of an infectious agent. To minimize this risk, the donors will be selected preferentially from a spouse or sexual partner. If this is not possible, then another relative or acquaintance would serve as the donor as identified by the recipient. In either case, the donor will be screened for potentially transmissible infections. This will include a health screening questionnaire adapted from Canadian Blood Services, a clinical examination and laboratory investigations to rule out known transmissible infectious diseases. The donor will complete a satisfaction survey.

The submitted stool will be processed in the lab as per the "Stool Prep Protocol". The route of administration will be by retention enema via a rectal tube. As the treatment is not an emergency the investigators will have the option, if necessary, to store the stool for future treatment. If the sample is not used it will be discarded at 90 days and another sample will be obtained if still required.

Prior to the treatment the recipient will also submit a sample of stool. Along with this a portion of the donor sample will be stored in at -80 degrees C for future molecular tests to determine the diversity of the microbiota. This may be performed at a later date dependent on obtaining the necessary funding.

Recipients will be followed for 6 months post FMT to monitor for success of treatment, adverse reactions, recipient satisfaction and a quality of life assessment.

note: if laboratory testing for Clostridium difficile (CD) changes the new test will replace the cytotoxicity test.

Eligibility criteria: Inclusion Criteria:

1. Adults aged ≥ 18 yrs of age.
2. Recurrent CDI despite two courses of standard treatment (ie. 10 days of oral vancomycin or metronidazole) and a 6 week taper of oral vancomycin.
3. Laboratory confirmation of CDI by enzyme immunoassay (EIA), cytotoxicity assay and/or polymerase chain reaction (PCR).
4. Presence of persistent diarrhea defined as ≥ 3 loose or watery bowel movements in 24hr continuing for \>2 days and diarrhea ongoing at the time of inclusion.

Exclusion Criteria:

1. Severely immunosuppressed patients will not be enrolled. This is defined as \>20 mg prednisone/d for \>1 month, recent transplant patients (haematological \<2yrs and solid organ \< 6 months), transplant with active graft versus host disease, HIV (with CD4\<200), immunosuppressive antibody treatment (eg. tumour necrosis factor inhibitor, rituximab), other high dose long term systemic immunosuppression) and severe congenital immunodeficiency.
2. Age \<18 years old.
3. Pregnancy.
4. Patient expected to expire in \< 30d.
5. Current hospital admission for an indication other than CDI or need for vasopressor medication.

Primary outcomes:
measure: Resolution of CDI
timeFrame: 30 days
Secondary outcomes:
measure: Success of treatment
timeFrame: 3 months
measure: Adverse effects
timeFrame: 6 months
measure: Quality of life
timeFrame: day 0, 3 months and 6 months
measure: Recipient Satisfaction
timeFrame: 1week, 3 months and 6 months
measure: Donor Satisfaction
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Dalhousie University, Department of Medicine, Division Infectious Diseases
name: Ian R Davis, MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References: