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

Stopped early · Phase 2/Phase 3

Conditions studied: Positive C-Diff Culture

In brief

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).

Key facts

Study ID

NCT00177775

Run by

University of Pittsburgh

People needed

60

Starts

2005-04-01

Expected to finish

2005-08-01

Last updated by the study team

2008-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.