Multi-Centre Trial of Fresh vs. Frozen-and-Thawed HBT(Fecal Transplant)for Recurrent CDI

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by McMaster University
Sponsor:
Collaborators:
St. Joseph's Healthcare Hamilton
Hamilton Health Sciences Corporation
Kingston General Hospital
Queen's University
University of Alberta
Vancouver General Hospital
Information provided by (Responsible Party):
Christine H. Lee, McMaster University
ClinicalTrials.gov Identifier:
NCT01398969
First received: July 19, 2011
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

The goal of this study is to determine the outcome of patients with recurrent CDI treated with fresh HBT versus frozen-and-thawed HBT in a randomized controlled trial. The specific objectives are to evaluate the safety of both types of HBT and to compare the clinical response, treatment failure and relapse rate in patients treated with fresh HBT compared to those treated with frozen-and-thawed HBT; also to assess the functional health and well-being of patients in each arm using a validated tool. The metagenomics will also be conducted from the stool samples collected from select patients from each arm: pre and post treatment and the matching donors. The metagenomics data will be used to determine the bacteria which may have contributed to the cure of CDI.


Condition Intervention Phase
Clostridium Difficile Infection
Procedure: Fresh Human Biotherapy
Procedure: Frozen-and-Thawed Human Biotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Multi-Centre Trial of Fresh vs. Frozen-and-Thawed Human Biotherapy (Fecal Transplant) for Recurrent Clostridium Difficile Infection

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • The evaluation of the safety of HBT [ Time Frame: 13 Weeks post HBT ] [ Designated as safety issue: Yes ]
    Assessment for adverse reactions in each study group by history, physical examination, blood work at baseline, day 12, week 5 and at completion (week 13) of the study period.

  • To evaluate the clinical response rate of HBT in each arm. [ Time Frame: 13 Weeks post HBT ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to resolution of diarrhea [ Time Frame: 13 Weeks post HBT ] [ Designated as safety issue: Yes ]
  • To determine the relapse rate of clinical and laboratory evidence of CDI within the 13-week study period in participants treated with fresh HBT in comparison to frozen thawed HBT. [ Time Frame: 13 Weeks post HBT ] [ Designated as safety issue: Yes ]
  • Assessment of the functional health and well-being of patients [ Time Frame: Up to week 13 ] [ Designated as safety issue: No ]
    Patients will be asked to fill in the self-administered Health Survey at day 12, week 5, and week 13.


Estimated Enrollment: 136
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fresh Human Biotherapy
Patients in this arm will receive a Fresh HBT enema. They will be followed 13 weeks to assess the cure or recurrence of CDI. All procedures across the two arms will be identical.
Procedure: Fresh Human Biotherapy
Patients will receive fresh fecal enema (supernatant of fecal specimen mixed with water) on day 1. If cure is not reached at day 5 (+3) a repeat HBT will be performed
Other Name: Fresh Fecal Transplantation
Experimental: Frozen-and-Thawed Human Biotherapy
Patients in this arm will receive a Frozen then Thawed HBT enema. They will be followed 13 weeks to assess the cure or recurrence of CDI. All procedures across the two arms will be identical.
Procedure: Frozen-and-Thawed Human Biotherapy
Patients will receive frozen-and-thawed fecal enema (supernatant of fecal specimen mixed with water) on day 1. If cure is not reached at day 5 (+3) a repeat HBT will be performed
Other Name: Frozen-and-Thawed Fecal Transplantation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patient inclusion criteria

  1. Age 18 years or older.
  2. Able to provide informed consent.
  3. Laboratory or pathology: confirmed diagnosis of recurrent CDI with symptoms (defined below) within the previous 180 days.
  4. ≥ 2 episodes of CDI within 6 months and/or ongoing symptoms consistent with CDI despite treatment with oral vancomycin at a dose of at least 125 mg 4 times daily for at least 5 days.

Symptoms of CDI, diarrhea defined as: 3 or more unformed bowel movements in 24 hours for a minimum of 2 days with no other causes for diarrhea. Subjects will be required to have laboratory or pathology-confirmed diagnosis of recurrent C. difficile infection where recurrence is defined as return of diarrhea and positive stool test after a period of symptom resolution within 8 weeks of the first episode and has received at least a 10-day course of standard antibiotic therapy.

Patient exclusion criteria

  1. Planned or actively participating in another clinical trial.
  2. Patients with neutropenia with absolute neutrophil count <0.5 x 109/L
  3. Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray
  4. Peripheral white blood cell count > 30.0 x 10E9/L AND temperature > 38.0 oC
  5. Active gastroenteritis due to Salmonella, Shigella, E. coli 0157H7, Yersinia or Campylobacter.
  6. Presence of colostomy
  7. Unable to tolerate HBT or enema for any reason.
  8. Requiring systemic antibiotic therapy for more than 7 days.
  9. Actively taking Saccharomyces boulardii
  10. Severe underlying disease such that the patient is not expected to survive for at least 30 days.
  11. Any condition that, in the opinion of the investigator, that the treatment may pose a health risk to the subject.

Donor inclusion

  1. Able to provide and sign informed consent.
  2. Able to complete and sign the donor questionnaire
  3. Able to adhere to fecal transplantation stool collection standard operating procedure.

Donor exclusion

  1. Tested positive for any of the following: Human Immunodeficiency virus (HIV) 1/2, hepatitis IgM, hepatitis B (HBsAg), hepatitis C antibody, syphilis, human T- lymphotrophic virus (HTLV) 1/II and vancomycin resistant Enterococcus (VRE), methicillin resistant S. aureus (MRSA), Salmonella, Shigella, E.coli O157 H7, Yersinia and Campylobacter.
  2. Detection of ova, parasites, C. difficile toxin, norovirus, adenovirus, rotavirus on stool examination
  3. History of any type of active cancer or autoimmune disease
  4. History of risk factors for acquisition of HIV, syphilis, Hepatitis B, Hepatitis C, prion or any neurological disease as determined by the donor questionnaire, appendix B.
  5. History of gastrointestinal comorbidities, e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation or diarrhea
  6. Receipt of blood transfusion from a country other than Canada in preceding 6 months
  7. Antibiotic use or any systemic immunosuppressive agents in the 3 months prior to stool donation
  8. Receipt of any type of live vaccine within 3 months prior to stool donation
  9. Ingestion of nut or shell fish 3 days preceding donation if the recipient has known allergies to these food.
  10. Any current or previous medical or psychosocial condition or behaviours which in the opinion of the investigator may pose risk to the recipients or the donor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398969

Contacts
Contact: Christine Lee, MD, FRCPC 905 522 1155 ext 36021 clee@mcmaster.ca
Contact: Jane Belanger, MSc 905 521 6143 jbelange@stjoes.ca

Locations
Canada, Alberta
University of Alberta Hospital Not yet recruiting
Edmonton, Alberta, Canada, T6G 2P4
Contact: Dina Kao, MD    780-492-8307    dkao@ualberta.ca   
Principal Investigator: Dina Kao, MD         
Canada, British Columbia
Vancouver Coastal Health (VCHRI/VCHA) - Diamond Health Care Centre and Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Theodore Steiner, MD    604-875-4588    tsteiner@mail.ubc.ca   
Principal Investigator: Theodore Steiner, MD         
Canada, Ontario
St. Joseph's Hospital Recruiting
Hamilton, Ontario, Canada, L8N4A6
Contact: Christine Lee, MD    905 521 6021    clee@mcmaster.ca   
Contact: Jane Belanger, MS    905 521 6143    jbelange@stjoes.ca   
Principal Investigator: Christine Lee, MD, FRCPC         
Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L2V7
Contact: Elaine Petrof, MD    6135496666 ext 6516    eop@queensu.ca   
Principal Investigator: Elaine Petrof, MD, MSc         
Sponsors and Collaborators
McMaster University
St. Joseph's Healthcare Hamilton
Hamilton Health Sciences Corporation
Kingston General Hospital
Queen's University
University of Alberta
Vancouver General Hospital
Investigators
Principal Investigator: Christine Lee, MD St. Joseph's Healthcare Hamilton
  More Information

No publications provided

Responsible Party: Christine H. Lee, Physician, McMaster University
ClinicalTrials.gov Identifier: NCT01398969     History of Changes
Other Study ID Numbers: CDI.HBT.1
Study First Received: July 19, 2011
Last Updated: February 27, 2014
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Randomized
Double Blind
Fecal Transplant
Recurrent
Clostridium difficile infection
CDI
HBT
Diarrhea
Frozen HBT
Thawed HBT
Fecal Enema

ClinicalTrials.gov processed this record on August 28, 2014