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FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI

This study is currently recruiting participants.
Verified March 2016 by Becky Smith, NorthShore University HealthSystem
Sponsor:
ClinicalTrials.gov Identifier:
NCT02255305
First Posted: October 2, 2014
Last Update Posted: March 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Becky Smith, NorthShore University HealthSystem
  Purpose
The purpose of the study is to determine the safety and efficacy of Fecal Microbiota Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI) as compared to standard antibiotic therapy. Patients who have tested positive for CDI within 90 days of an admission for relapse of CDI will be approached to participate in this open-label, randomized controlled trial. Patients will either be randomized to the intervention group (receive FMT via retention enema) or the control group (receive antimicrobials targeting CDI).

Condition Intervention Phase
Clostridium Difficile Infection Biological: FMT Drug: Antimicrobials Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation Versus Standard Medical Therapy for Initial Treatment of Recurrent Clostridium Difficile Infection

Resource links provided by NLM:


Further study details as provided by Becky Smith, NorthShore University HealthSystem:

Primary Outcome Measures:
  • Clinical Resolution of Diarrhea [ Time Frame: 90 days ]
    Patients will be followed after their procedure to assess for adverse symptoms and relapse of C. difficile infection. Patients will be visited daily during their hospital stay; patients will complete a telephone follow-up call 1 week post-procedure; and patients will complete a clinic visit at 30 days. At the 30-day clinic visit, patients will submit a stool sample to complete C. difficile PCR testing as well as co-colonization of the gastrointestinal tract with multidrug-resistant organisms. Patients will complete a telephone follow up at 3 months and 6 months.


Secondary Outcome Measures:
  • Time to Clinical Resolution of Symptoms [ Time Frame: 6 months ]
    Patients will be monitored after the procedure to assess number of daily bowel movements, presence/absence of abdominal pain, white blood cell count, creatinine, and temperature.

  • Hospital Length of Stay [ Time Frame: 1 week ]
    Patients' length of stay post-procedure will be measured. In addition, whether patients were admitted through the ICU and their length of stay in the ICU will be measured.

  • Readmission and Mortality [ Time Frame: 90 days ]
    Patients' readmission for recurrent Clostridium difficile infection will be measured. In addition, patient mortality will be assessed at 90 days post-procedure.


Estimated Enrollment: 60
Study Start Date: January 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FMT Group (Intervention Arm)
Patients randomized to the FMT group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists.
Biological: FMT
Patients in the FMT group will receive ~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.
Other Names:
  • Fecal Microbiota Transplant
  • Stool Transplant
Active Comparator: Antimicrobial Group (Control Arm)
Patients randomized to the antimicrobial group will be treated with antibiotics targeting C. difficile according to the Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines for CDI. FMT will be offered to this group after 90 days if they experience relapsing CDI.
Drug: Antimicrobials
Patients randomized to the control group will receive antimicrobials targeting C. difficile.

Detailed Description:

This trial is an open-label, randomized, controlled trial evaluating the safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI) as compared to standard antibiotic therapy. Clostridium difficile infection (CDI) has increased in incidence and severity over the last decade and is associated with poor outcomes including increased morbidity, mortality, and healthcare costs (1-8). Relapse occurs in 15-35% of patients after the first episode of CDI and 45-65% of patients who have one relapse will experience a subsequent relapse (9, 10). Dysbiosis - decreased diversity of the fecal microbiome - is thought to contribute to the high rate of relapse (11). FMT quickly and successfully restores normal intestinal microorganisms of the diseased patient via infusion of a liquid stool preparation from a healthy donor. FMT resulted in disease resolution in ~90% of cases reported in a systematic review and meta-analyses without any significant adverse events noted (12, 13).

All hospitalized patients in the NorthShore system >18 years of age who are diagnosed with active CDI, defined as >3 diarrheal stools per day and a positive C. difficile PCR assay, will be evaluated for inclusion in the study. Hospitalized patients presenting with their first or greater relapse of CDI occurring between 15 and 90 days after an index episode of CDI will be eligible for enrollment. Exclusion criteria will include pregnancy, neutropenia (absolute neutrophil count <1000/μl), contraindication for retention enema, or food allergy not controlled for in the donor diet. Eligible patients will undergo written informed consent followed by randomization into intervention and control groups.

Patients who are randomized to the intervention group will have antimicrobials targeting C. difficile discontinued at least 6 hours prior to undergoing an FMT via retention enema. A second FMT via retention enema will be administered at 24 hours if diarrhea persists. Patients randomized to the control group will be treated with antimicrobials targeting C. difficile according to the Society for Healthcare Epidemiology of America Clinical Practice Guidelines for CDI (18). FMT will be offered to the control group after 90 days if they experience relapsing CDI.

Two healthy "universal" donors who have previously donated fecal material for FMT have expressed willingness to participate in the study. Donors will complete the American Association of Blood Banks donor questionnaire for exposure to infectious agents as well as undergo serologic and stool testing for communicable diseases or pathogenic bacteria/viruses as previously described (17).

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosis of active C. difficile infection, defined as > 3 diarrheal stools per day and a positive C. difficile PCR assay
  • Hospitalized patient presenting with first relapse of CDI occuring between 15 and 90 days after an index episode of CDI

Exclusion Criteria:

  • Pregnancy
  • Neutropenia (absolute neutrophil count <1000/microliters)
  • Contraindication for retention enema
  • Food allergy not controlled in the donor diet
  Contacts and Locations
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): NCT02255305


Contacts
Contact: Becky Smith, MD 847-570-1502 bsmith@northshore.org
Contact: Edessa David, BA 847-570-3708 edavid2@northshore.org

Locations
United States, Illinois
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Edessa David, BA    847-570-3708    edavid2@northshore.org   
Contact: Colleen Leonard, BA    847-570-3558    cleonard@northshore.org   
Principal Investigator: Becky Smith, MD         
Sub-Investigator: Eugene Yen, MD         
Sponsors and Collaborators
NorthShore University HealthSystem
Investigators
Principal Investigator: Becky Smith, MD NorthShore University HealthSystem
  More Information

Publications:

Responsible Party: Becky Smith, Hospital Epidemiologist, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT02255305     History of Changes
Other Study ID Numbers: EH 14-331
First Submitted: September 30, 2014
First Posted: October 2, 2014
Last Update Posted: March 23, 2016
Last Verified: March 2016

Keywords provided by Becky Smith, NorthShore University HealthSystem:
CDI
C difficile
C diff
Clostridium difficile

Additional relevant MeSH terms:
Infection
Anti-Infective Agents
Anti-Bacterial Agents