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

• Status: Terminated
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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. Secondary objectives will investigate the effectiveness of MucoMilk® as an aid in the prevention of relapse of C. difficile-associated diarrhea (CDAD).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: MucoVax, BV, the Netherlands

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.