Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection

Phase 2

Terminated

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Open Label CASAD	Calcium Aluminosilicate Anti-Diarrheal (CASAD)	Treatment with CASAD for 14 days

Primary Outcome Measures

Name	Time	Method
Resolution of Diarrhea	42 days	To evaluate the safety and efficacy of CASAD added to the standard-of-care for the therapy of Clostridium difficile infection (C. difficile).

Secondary Outcome Measures

Name	Time	Method
Stools Per Day	14 days	Compare the number of liquid stools per day during treatment period
Resolution of Abdominal Pain	14 days	Compare time to resolution of abdominal pain
Absence of Relapse	42 days	Compare sustained clinical response
Side-effects and Complications	42 days	Compare side-effects and complications