Status:
COMPLETED
Fecal Microbial Transplantation for C. Difficile and/or Ulcerative Colitis or Indeterminate Colitis
Lead Sponsor:
Stony Brook University
Conditions:
Clostridium Difficile Infection
Ulcerative Colitis
Eligibility:
All Genders
7+ years
Phase:
EARLY_PHASE1
Brief Summary
Fecal Microbiota Transplantation will be offered to eligible C. difficile patients (does not require Investigational New Drug designation) and to eligible ulcerative colitis or indeterminate colitis p...
Detailed Description
The following hypothesis will be tested in this study: 1. Fecal microbiota transplantation is a safe, tolerable, and efficacious procedure for C. difficile patients and is a safe and tolerable proced...
Eligibility Criteria
Inclusion
- For C. difficile patients/recipients only:
- Inclusion:
- 1\. Patient is 7 years of age or older. 2. One of the following: 2a. At least two recurrences (total three CDI infections) of mild to moderate C. difficile (\<6 diarrheal stools/day) diagnosed by positive toxin PCR or EIA after completing standard medical therapy with metronidazole, vancomycin or fidaxomicin.
- 2b. At least two episodes of severe C. difficile infection (\>6 diarrheal stools/day requiring hospitalization and associated with significant morbidity).
- 2c. Moderate C. difficile infection (3-6 diarrheal stools/day not responding to successive standard therapy, e.g. metronidazole, vancomycin and/or fidaxomicin) lasting at least 28 days.
- 2d. Severe and/or fulminant C. difficile colitis (\> 6 diarrheal stools/day) with no response to standard therapy after 48 hours.
- Exclusion:
- younger than 7 year old
- scheduled for abdominal surgery within the next 12 weeks
- had major abdominal surgery within the past 3 months
- pregnancy
- Hemoglobin \< 6 g/dL
- absolute neutrophil count less than 1500/mm3
- known diagnosis of graft vs. host disease
- used an investigational drug within the past 2 months
- used a TNFα agonist within the past 2 weeks
- diagnosed with Bacteremia within the past 4 weeks
- For patients with ulcerative and indeterminate colitis only:
- Inclusion:
- Patient is 7 years of age or older.
- One of the following:
- 2a. treated with steroid therapy for at least one month. 2b. treated with immunomodulatory therapy for at least one month 2c. treated with biological therapy for at least one month.
- Exclusion:
- younger than 7 years old
- scheduled for abdominal surgery within the next 12 weeks
- had major abdominal surgery within the past 3 months
- pregnancy
- Hemoglobin \< 6 g/dL
- absolute neutrophil count less than 1500/mm3
- known diagnosis of graft vs. host disease
- used an investigational drug within the past 2 months
- used a TNFα agonist within the past 2 weeks
- diagnosed with Bacteremia within the past 4 weeks
- previous FMT
Exclusion
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03268213
Start Date
November 1 2013
End Date
February 15 2022
Last Update
February 22 2022
Active Locations (1)
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1
Stony Brook University Hospital
Stony Brook, New York, United States, 11794