Clostridium Difficile-Associated Diarrhea
Conditions
Keywords
Clostridium difficile, diarrhea, colostrum
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).
Interventions
DRUGColostrum
Daily administration of Colostrum derived antibodies against C. difficile.
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Disease severity - duration, maximal intensity (number of stools) in index cases. | 60 days |
| Eradication of Clostridium difficile from stools | 1 year |
Countries
Israel
Outcome results
None listed