Whey Protein Concentrate 40% Made of Milk of Immunized Cows to Aid in the Prevention of Relapse of Clostridium Difficile-Diarrhea

This study has been terminated.
(Study is completed and analysis completed)
Sponsor:
Collaborator:
MucoVax, BV, the Netherlands
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177775
First received: September 13, 2005
Last updated: December 16, 2008
Last verified: December 2008
  Purpose

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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • To investigate the effectiveness of MucoMilk®

Secondary Outcome Measures:
  • To assess the safety of MucoMilk

Estimated Enrollment: 60
Study Start Date: April 2005
Estimated Study Completion Date: August 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligible subjects must meet all of the following inclusion criteria:

  • Willingness and ability to comply with all study requirements, to fully understand all elements of informed consent, and to provide written informed consent.
  • Confirmed CDAD by ELISA toxin assay or cell test.
  • Are currently receiving or have received standard antibiotic treatment for CDAD with oral/intravenous metronidazole and/or vancomycin for a minimum of 10 days per standard of care at the discretion of the study physician.
  • Resolution of diarrhea to a maximum of 3 stools per day following completion of antibiotic therapy.
  • Ability to tolerate fluids by mouth or by feeding tube.
  • Have passage of stools.

Exclusion Criteria:

Subjects will not be eligible to participate in this study if any of the following exclusion criteria apply:

  • Unable to provide informed consent.
  • History of lactose intolerance.
  • Cannot tolerate fluids by mouth or by feeding tube, or are judged by the attending physician unfit to receive fluids by mouth or by feeding tube.
  • Have received an investigational drug within 4 weeks prior to study entry.
  • Have underlying gastrointestinal tract disease characterized by diarrhea or unformed stools.
  • Are currently receiving any antidiarrheal medications.
  • Current use of an ileostomy or colostomy.
  • History of milk allergy.
  • Current use of Saccharomyces boulardii, Lactinex, or Culturelle preparations at start of study. (S. boulardii is a non-colonizing yeast species purported to support gastrointestinal tract function. It has been widely studied and used to help prevent post-antibiotic diarrhea.)
  • Reside outside of the United States.
  • Cannot speak or read English.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177775

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
MucoVax, BV, the Netherlands
Investigators
Principal Investigator: Peter Veldkamp, MD University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00177775     History of Changes
Other Study ID Numbers: IRB# 0412033
Study First Received: September 13, 2005
Last Updated: December 16, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 20, 2014