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

Study Overview
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Brief Summary
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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.

Official Title
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Proof-of-Concept, CASAD for Treatment of Clostridium Difficile Infection

Conditions
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Diarrhoea, Clostridium Difficile

Intervention / Treatment
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* Drug: Calcium Aluminosilicate Anti-Diarrheal (CASAD)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label CASAD<br>Treatment with CASAD for 14 days | Drug: Calcium Aluminosilicate Anti-Diarrheal (CASAD)<br>* CASAD 3 500mg capsules po tid for 14 days with 4 weeks of follow up<br>* Other names: CASAD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of Diarrhea | To evaluate the safety and efficacy of CASAD added to the standard-of-care for the therapy of Clostridium difficile infection (C. difficile). | 42 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clostridium difficile, infection, diarrhea, cramping