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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00377078
Recruitment Status : Unknown
Verified September 2006 by Johns Hopkins University.
Recruitment status was:  Recruiting
First Posted : September 15, 2006
Last Update Posted : September 15, 2006
Ventria Bioscience
Information provided by:
Johns Hopkins University

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 feeding requiring broad spectrum antibiotics.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Drug: recombinant human lactoferrin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes to Manage Post-Antibiotic Colonization and Infection With Clostridium Difficile
Study Start Date : October 2005
Study Completion Date : October 2007

Primary Outcome Measures :
  1. Subjects receive 3 grams of lactoferrin in a flush solution for the automated enteric feeding system.
  2. Dosing will begin with antibiotic dosing

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00377078

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Contact: William B Greenough, III, MD 410-550-0782

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United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: William B Greenough, III, M.D.    410-550-0782   
Sponsors and Collaborators
Johns Hopkins University
Ventria Bioscience
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Principal Investigator: William B Greenough, III, MD Johns Hopkins University
Study Director: Delia Bethell, Ph.D. Ventria Bioscience
Study Chair: Delia Bethell, Ph.D. Ventria Bioscience
Layout table for additonal information Identifier: NCT00377078    
Other Study ID Numbers: CP-VB-04-02
First Posted: September 15, 2006    Key Record Dates
Last Update Posted: September 15, 2006
Last Verified: September 2006
Keywords provided by Johns Hopkins University:
recombinant human lactoferrin
Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Infective Agents