Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT03795233
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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)-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03795233
Study Brief:
Protocol Section:
NCT03795233