Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes With Clostridi… (NCT00377078) | Clinical Trial Compass
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Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes With Clostridium Difficile.
United States30 participantsStarted 2005-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Subjects receive 3 grams of lactoferrin in a flush solution for the automated enteric feeding system.