FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI
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|ClinicalTrials.gov Identifier: NCT02255305|
Recruitment Status : Recruiting
First Posted : October 2, 2014
Last Update Posted : March 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Biological: FMT Drug: Antimicrobials||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fecal Microbiota Transplantation Versus Standard Medical Therapy for Initial Treatment of Recurrent Clostridium Difficile Infection|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||December 2018|
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.
Patients in the FMT group will receive ~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.
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.
Patients randomized to the control group will receive antimicrobials targeting C. difficile.
- 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.
- 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.
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
|Contact: Becky Smith, MDfirstname.lastname@example.org|
|Contact: Edessa David, BAemail@example.com|
|United States, Illinois|
|NorthShore University HealthSystem||Recruiting|
|Evanston, Illinois, United States, 60201|
|Contact: Edessa David, BA 847-570-3708 firstname.lastname@example.org|
|Contact: Colleen Leonard, BA 847-570-3558 email@example.com|
|Principal Investigator: Becky Smith, MD|
|Sub-Investigator: Eugene Yen, MD|
|Principal Investigator:||Becky Smith, MD||NorthShore University HealthSystem|