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

Status unconfirmed · Not applicable

Conditions studied: Clostridium Difficile

In brief

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.

Key facts

Study ID: NCT00377078
Run by: Johns Hopkins University
People needed: 30
Starts: 2005-10-01
Expected to finish: 2007-10-01
Last updated by the study team: 2006-09-15

Who can join

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

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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