Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection
Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection
Clostridium difficile (C. difficile) can cause symptoms ranging from mild diarrhea to
 life-threatening colitis. Illness from C. difficile most commonly affects patients in
 hospitals and long-term care facilities and typically occurs after a patient has received
 antibiotics.

 In vitro data indicate Calcium Aluminosilicate Anti-Diarrheal (CASAD) has the potential to
 bind TNFα, IL-1, IL-6, and IL-10 in the intestines and, therefore, may act to reduce severity
 of fever, leukocytosis, and bowel injury in patients with C. difficile infection. This would
 likely occur in conjunction with neutralization of C. difficile toxins A&B by CASAD. Computer
 modeling of CASAD performed by Phillips et al. at Texas A&M University supports this
 hypothesis.

 The investigators hypothesize that adding CASAD 1.5 grams po tid to any standard-of-care
 therapy will reduce the duration and severity of diarrhea and other symptoms in patients with
 C. difficile infection.
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.