Status:
TERMINATED
Whey Protein Concentrate 40% Made of Milk of Immunized Cows to Aid in the Prevention of Relapse of Clostridium Difficile-Diarrhea
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
MucoVax, BV, the Netherlands
Conditions:
Positive C-Diff Culture
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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...
Detailed Description
This is a single-center, prospective, controlled, randomized, open-label study. Sixty subjects will be randomized 2:1 to receive MucoMilk® (n=40) or to the control arm with no specific product interve...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00177775
Start Date
April 1 2005
End Date
August 1 2005
Last Update
December 17 2008
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213