Status:
UNKNOWN
Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes With Clostridium Difficile.
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Ventria Bioscience
Conditions:
Clostridium Difficile
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Primary objective of this pilot study is to evaluate the effect of recombinant human lactoferrin on the rate of infection with Clostridium difficile in long-term care patients supported by enteral fee...
Detailed Description
This study is a prospective, randomized, double blind, placebo controlled comparison. Product to be tested: Lactoferrin (human) derived from rice. Amount, dosage, route of administration, duration:S...
Eligibility Criteria
Inclusion
- Patients in long-term care facility, Ventilator Rehabilitation Unit (VRU) (Plaza) at the John Burton Care Center of the Johns Hopkins Bayview Medical Center.
- Nutrition via gastrostomy, naso-gastric or jejunostomy enteral feeding system.
- Patients with supplemental oral intake, but primary nutrition via gastrostomy/jejunostomy tube.
- Patients with colostomies are also allowed
- Not currently on antibiotic therapy and no antibiotics within 10 days.
- Patient is negative for Clostridium difficile antigen in screen
- Patient, guardian or health care agent willing to give informed consent.
Exclusion
- Patients who will only receive vancomycin, linezolid, or metronidazole as the antibiotic treatment, not broad spectrum antibiotics. All other antibiotics will qualify.
- Patients with illeostomies.
- Patients who have signs or symptoms of C. difficile infection; such as diarrhea (two or more liquid stools in a 24-hour period) and elevated WBC (more than 15,000/mm3).
- Known allergy to rice or rice products.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00377078
Start Date
October 1 2005
End Date
October 1 2007
Last Update
September 15 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224