Clostridium Difficile
Conditions
Keywords
C-Diff, Diarrhea
Brief summary
This study was developed in response to the July, 2013 FDA draft guidance regarding FMT for CDI. The weight of the evidence in the literature suggests that FMT is the most effective treatment for ambulatory outpatients affected by recurrent CDI who fail conventional therapy. The anticipated benefits to research patients enrolled in this study include resolution of chronic diarrhea, return of bowel habits and nutritional status to normal, and resolution of chronic recurrent CDI. FMT involves the endoscopic instillation of freshly obtained stool with millions of live bacteria into the recipient's colon by endoscopic lavage. With any endoscopic procedure, there is a risk of perforated viscous. This is very rare, but the risk is increased with severe CDI. The risk of acquisition of communicable enteric or blood borne pathogen appears to be negligible.
Interventions
BIOLOGICALStool
Implanting fecal matter via colonscope
Sponsors
OSF Healthcare System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients \> 18 years of age 2. The patient has been treated with appropriate antimicrobial therapy for CDI. 3. The patient has documented relapse/recurrence of infection as demonstrated by positive stool culture, or cytotoxin assay, or PCR toxin assay. 4. Since this study does not involve treatments that have potential teratogenicity, and in general avoidance of antimicrobial treatment during pregnancy is advised (metronidazole is pregnancy category C), women of child-bearing age may be included in the study.
Exclusion criteria
\- Patients will be excluded from study participation if one of the following categories of
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight and Number of bowel movements/day | 30 and 90 days | In the present study we will record each subjects weight and number of bowel movements/day prior to FMT and following FMT at 30 and 90 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the most appropriate patient population for FMT | 30 and 90 days | Our study will include ambulatory outpatients as well as hospitalized, debillitated patients. FMT has demonstrated effectiveness (both systematic reviews and RCT) for treatment of recurrent Clostridium difficile infection in ambulatory outpatient populations. A secondary outcome of our study is to evaluate stratify our patient population and examine FMT success rates for out two primary outcome measures in outpatients vs. inpatients. |
| Determine the overall success of FMT | 30 and 90 days | An additional secondary outcome measure will be to examine the percent of patients who undergo 2nd or third FMT. and the success rate (in terms of primary outcome measures) for each subsequent FMT. |
Countries
United States
Contacts
Primary ContactApril A Howarter, BSN
Outcome results
None listed