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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 24, 2014