Safety and Validation of Efficacy of Oral Administration of the Food Additive Colostrum Derived Anti Clostridium Difficile Antibodies
Phase 2
Withdrawn
- Conditions
- Clostridium Difficile-Associated Diarrhea
- Interventions
- Drug: Colostrum
- Registration Number
- NCT00747071
- Lead Sponsor
- Hadassah Medical Organization
- 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 difficile associated disease (CDAD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Colostrum Hospitalized patients with Clostridium difficile associated diarrhea. 2 Colostrum Close hospital contacts of each index case
- Primary Outcome Measures
Name Time Method Recurrence of active Clostridium difficile associated diarrhea in index cases 60 days New cases of Clostridium difficile associated diarrhea in close hospital contacts. 60 days
- Secondary Outcome Measures
Name Time Method Disease severity - duration, maximal intensity (number of stools) in index cases. 60 days Eradication of Clostridium difficile from stools 1 year
Trial Locations
- Locations (1)
Hadassah Medical Organization
🇮🇱Jerusalem, Israel