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

Clostridium Difficile-Associated Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00747071
• Other study ID #: 0180-08-HMO - CTIL
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: September 3, 2008
• Last updated: August 27, 2012
• Start date: September 2011
• Est. completion date: November 2013

Study information

• Verified date: June 2011
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Clostridium Difficile-Associated Diarrhea

Intervention

Drug:
• Colostrum
Daily administration of Colostrum derived antibodies against C. difficile.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of active Clostridium difficile associated diarrhea in index cases		60 days	No
Primary	New cases of Clostridium difficile associated diarrhea in close hospital contacts.		60 days	No
Secondary	Disease severity - duration, maximal intensity (number of stools) in index cases.		60 days	No
Secondary	Eradication of Clostridium difficile from stools		1 year	No