Status:
TERMINATED
Fecal Microbiota Transplant for Primary CDI
Lead Sponsor:
Boston Medical Center
Conditions:
Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Clostridium difficile infection (CDI) is one of the most urgent health threats in the U.S. associated with antibiotic use. After an initial episode, disease recurrence is high and relapses can occur i...
Detailed Description
Population: Patients \>= 18 years hospitalized at Boston Medical Center (BMC) with a first documented episode of CDI. Intervention: 30 FMT capsules administered orally under direct observation within...
Eligibility Criteria
Inclusion
- Diagnosis of primary clostridium difficile infection (CDI) defined by the presence of diarrhea and a positive C. difficile Polymerase chain reaction (PCR) test
- Admitted to Boston Medical Center
- English speaking
Exclusion
- Primary CDI treatment failure
- History of CDI
- Diagnosis of inflammatory bowel disease, immunocompromised state, or active malignancy
- Dysphagia: oropharyngeal, esophageal, functional, neuromuscular (e.g. stroke, multiple sclerosis, ALS), or patient shows evidence of dysphagia when the 'safety test' capsule is administered
- History of aspiration
- History of gastroparesis
- History of intestinal obstruction
- Severe food allergy (e.g. anaphylaxis or anaphylactoid reaction) Adverse event attributable to a previous FMT
- Patients with allergies to sodium chloride, glycerol, theobroma oil, hide bovine gelatin, sodium lauryl sulfate, Food, Drugs \& Cosmetics certified colorants (FD\&C), or titanium dioxide, all ingredients Generally Recognized As Safe (GRAS)
- History of ongoing antibiotic use (e.g. nitrofurantoin for urinary tract infection (UTI) prophylaxis) Currently pregnant or breastfeeding -Any condition for which the treating physician thinks the treatment may pose a health risk (e.g. severely immunocompromised)-
Key Trial Info
Start Date :
August 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03795233
Start Date
August 23 2019
End Date
January 15 2021
Last Update
December 15 2021
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118