Status:
COMPLETED
Fecal Microbial Transplantation in Patients With Crohn's Disease
Lead Sponsor:
Stony Brook University
Conditions:
Crohn Disease
Eligibility:
All Genders
7+ years
Phase:
EARLY_PHASE1
Brief Summary
Fecal Microbiota Transplantation will be offered to eligible Crohn's disease patient as Investigational New Drug treatment
Detailed Description
The following hypothesis will be tested in this study: 1. Fecal microbiota transplantation is a safe, tolerable procedure. 2. The fecal microbial diversity, composition and function in stool recipien...
Eligibility Criteria
Inclusion
- Inclusion Criteria for initial Fecal Microbial Transplant for Crohn's disease:
- All patients age ≥7 years of age with established diagnosis of Crohn's disease made by a primary gastroenterologist based on history, physical examination, laboratory/radiological studies, and gastrointestinal histology, with one or more of the following criteria:
- has been treated with steroid therapy for at least a month
- has been treated with immunomodulatory therapy for at least a month
- has been treated with biological therapy for at leaset a month
- All patients or legal guardians of patients less than 18 years of age will have to give consent. The consent form will outline that although fecal microbiota transplantation appears safe based on past studies, a theoretical risk of transmission of an unrecognized infectious agent or substance exists and could result in an unexpected disease. All patients aged ≥7 and \<18 years will have to give assent
- Exclusion Criteria:
- Patients less than 7 years of age
- Scheduled for abdominal surgery within the next 12 weeks
- Major abdominal surgery within the past 3 months
- Pregnancy (This will be checked through a urine test on the day of procedure)
- Anemia: Hemoglobin \< 6 g/dL,
- Neutropenia: Absolute Neutrophil Count \<1500 Both of the above criteria will be checked via screening test or blood test reports within one month prior to the procedure
- A known diagnosis of graft vs. host disease
- Presence of an intra-abdominal or perianal abscess.
- Presence of intestinal cutaneous fistula
- Presence of severe intestinal stricture and/or intestinal obstruction
- Administration of any investigational drug within the past 2 months
- Use of a TNF-α antagonist within 2 weeks of the proposed date of transplantation
- Bacteremia within past 4 weeks (28 days)
- Severe Crohn's Disease, determined by Pediatric Crohns Disease Activity Index (PCDAI) value of more than 29.
- Individuals with severe prior allergic reaction to food;
- Individuals with intercurrent illness including but not necessarily limited to: febrile illness, decompensated liver cirrhosis, HIV/AIDS BMT within past 150 days, malignancy, or other severe immunodeficiency.
- Individuals at increased risk for complications of endoscopy or procedural sedation (e.g., ASA classification IV and above).
- Previous FMT
Exclusion
Key Trial Info
Start Date :
June 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03267238
Start Date
June 16 2017
End Date
February 15 2022
Last Update
February 21 2022
Active Locations (1)
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1
Stony Brook University Hospital
Stony Brook, New York, United States, 11794