Safety and Validation of Efficacy of Oral Administration of the Food Additive Colostrum Derived Anti Clostridium Difficile Antibodies

• Status: Withdrawn
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization
• Treatments: Antibodies; Immunoglobulins

Criteria

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