Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection
Condition: Diarrhoea, Clostridium Difficile
MeSH terms: Infections; Clostridium Infections; Diarrhea
Intervention: Calcium Aluminosilicate Anti-Diarrheal (CASAD)
Intervention description: CASAD 3 500mg capsules po tid for 14 days with 4 weeks of follow up
Intervention MeSH terms: Antidiarrheals; Loperamide; Calcium Aluminosilicate; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium difficile; infection; diarrhea; cramping

Summary:

      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.
    

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.