Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes With Clostridium Difficile.

• Status: Unknown status
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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 feeding requiring broad spectrum antibiotics.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Ventria Bioscience
• Treatments: Lactoferrin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.