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

Status Withdrawn

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).

Clinical Trial Description

n/a

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

Clinical Trial Details

NCT number	NCT00747071
Study type	Interventional
Source	Hadassah Medical Organization
Contact
Status	Withdrawn
Phase	Phase 2/Phase 3
Start date	September 2011
Completion date	November 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01591863` - Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)	Phase 2
Completed	`NCT00034294` - A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea	Phase 2
Completed	`NCT00958308` - Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection	Phase 3