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 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT01570634
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01570634
Study Brief:
Protocol Section:
NCT01570634