Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Pittsburgh MucoVax, BV, the Netherlands |
---|---|
Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00177775 |
The primary objective of this study is to assess the safety of the investigational agent, MucoMilk®, a polyclonal-antibody enriched Whey Protein Concentrate 40% (WPC-40) made of milk of immunized cows. Secondary objectives will investigate the effectiveness of MucoMilk® as an aid in the prevention of relapse of C. difficile-associated diarrhea (CDAD).
Condition | Intervention | Phase |
---|---|---|
Positive C-Diff Culture |
Drug: MucoMilk product |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Factorial Assignment |
Official Title: | Whey Protein Concentrate 40% (WPC-40) Made of Milk of Immunized Cows to Aid in the Prevention of Relapse of Clostridium Difficile-Diarrhea: A Prospective, Randomized, Controlled Phase II Study - Version 5.1.B |
Estimated Enrollment: | 60 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | August 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible subjects must meet all of the following inclusion criteria:
Exclusion Criteria:
Subjects will not be eligible to participate in this study if any of the following exclusion criteria apply:
United States, Pennsylvania | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Peter Veldkamp, MD | University of Pittsburgh |
Study ID Numbers: | IRB# 0412033 |
Study First Received: | September 13, 2005 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00177775 |
Health Authority: | United States: Institutional Review Board |
Diarrhea |