Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Salient Pharmaceuticals Incorporated
With
Scott and White Hospital & Clinic
Texas A&M University
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
C. difficile-associated diarrhea at the time of enrollment
18 years old and up
Ability to take oral medications
Negative urine pregnancy test for women of childbearing age
Must have the ability to understand and the willingness to provide a written informed consent to participate in the study
You may not be if
History of known allergy to silicates
Patients with signs of toxic megacolon, peritonitis, pseudomembranous colitis or bowel perforation
Patients with hypotension (systolic blood pressure \< 90 mm Hg) or septic shock requiring pressors
Patients with other known causes of diarrhea or colitis
Pregnancy or lactation
History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up
Participation in any other study where the subject is actively taking investigational medication within the last 30 days
More than 5 doses of metronidazole or oral vancomycin prior to starting on study drug for the current C. difficile diagnosis. Administration of metronidazole or oral vancomycin for treatment of prior C. difficile diagnosis is not exclusionary as some patients may be experiencing a relapse of C. difficile.
Any other antibiotic, toxin-binding agent or fecal transplant used for the treatment of C. difficile prior to or added to the subject's standard-of-care treatment regimen. Use of intravenous vancomycin is not exclusionary.
