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Fecal Microbiota Therapy for Recurrent Clostridium Difficile Infection

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ClinicalTrials.gov Identifier: NCT02686645
Recruitment Status : Not yet recruiting
First Posted : February 19, 2016
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Ian Davis, Queen Elizabeth II Health Sciences Centre

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

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Biological: Fecal Microbiota Drug: vancomycin Drug: Loperamide Drug: metronidazole Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Therapy for Recurrent Clostridium Difficile Infection
Study Start Date : December 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Fecal Microbiota Therapy
Vancomycin 125 mg po qid for 7 days or metronidazole 500 mg po tid for 7 days pre-treatment. Loperamide 4 mg po after morning prep and 2 mg post treatment. The route of administration fecal microbiota will be by retention enema via a rectal tube.
Biological: Fecal Microbiota
The fecal microbiota will be by retention enema administered through a rectal tube.

Drug: vancomycin
All subjects will be pre-treated with vancomycin 125 mg po qid X 7 days prior to the fecal microbiota.

Drug: Loperamide
The subject will take 4 mg of loperamide after the morning bowel prep (approximately 1 hour prior to the procedure) and 2 mg again after the procedure.

Drug: metronidazole
If unable to tolerate vancomycin, then it will be substituted with metronidazole 500 mg po tid X 7 days prior to the fecal microbiota.




Primary Outcome Measures :
  1. Resolution of CDI [ Time Frame: 30 days ]
    Resolution of CDI will be defined as < 3 bowel movements per day for 7 consecutive days or stool negative for Clostridium difficile (CD) on 2 consecutive stool sample at least 1 day apart within 30 days of the treatment.


Secondary Outcome Measures :
  1. Success of treatment [ Time Frame: 3 months ]
    Success of treatment with be absence of recurrence of CDI within 3 months of treatment. A recurrence will be defined as ≥ 3 bowel movements per day after a period of resolution with a positive stool for CD toxin within 3 months for treatment.

  2. Adverse effects [ Time Frame: 6 months ]
    Adverse effects experienced with treatment up to 6 months after treatment.

  3. Quality of life [ Time Frame: day 0, 3 months and 6 months ]
    Quality of Life Assessment (prior to, 3 month and 6 months after FMT) using the Short Form 36 (SF-36) Health Survey.

  4. Recipient Satisfaction [ Time Frame: 1week, 3 months and 6 months ]
    Recipient Satisfaction Survey which will be completed within 1 week of the FMT and again at 3 and 6 months post FMT.

  5. Donor Satisfaction [ Time Frame: 1 week ]
    The donor will complete a satisfaction survey within 1 week after the stool donation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686645


Contacts
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Contact: Ian R Davis, MD,FRCPC 902 473 8477 ian.davis@nshealth.ca

Sponsors and Collaborators
Queen Elizabeth II Health Sciences Centre
Investigators
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Principal Investigator: Ian R Davis, MD,FRCPC Dalhousie University, Department of Medicine, Division Infectious Diseases

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Responsible Party: Dr. Ian Davis, Assistant Professor Department of Medicine, Dalhousie University, Queen Elizabeth II Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02686645     History of Changes
Other Study ID Numbers: NSHA REB File #: 1020563
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Ian Davis, Queen Elizabeth II Health Sciences Centre:
Fecal Microbiota Transplantation
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Metronidazole
Vancomycin
Loperamide
Antidiarrheals
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Gastrointestinal Agents