Status:
WITHDRAWN
Safety and Validation of Efficacy of Oral Administration of the Food Additive Colostrum Derived Anti Clostridium Difficile Antibodies
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Clostridium Difficile-Associated Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This clinical study is designed to evaluate the safety and efficacy of oral administration of the food additive colostrum derived antibodies to Clostridium difficile for prevention of Clostridium diff...
Eligibility Criteria
Inclusion
- Age 18 or older
- Written informed consent
- At least 3 unformed or watery stools in each of the 2 previous 24 hour periods.
- Confirmed diagnosis of C. difficile associated diarrhea
Exclusion
- Pregnant or breast feeding women
- Known allergy to milk or milk products
- Other etiology of diarrhea
- Active or Chronic conditions: IBD, short bowel syndrome, ischemic colitis Ileus
- Pseudomembranous colitis
- White blood count \> 50,000
- Blood in stools
- Laxatives or motility drugs within 12 hours
- Inability to participate in adequate follow up
- Clinically unstable
- Investigator deems unsuitable
- Immune suppression (disease or treatment)
- GI surgery
- Past intestinal parasites
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00747071
Start Date
September 1 2011
End Date
November 1 2013
Last Update
August 28 2012
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91120