Recruiting

Recombinant Human Lactoferrin

Sponsor:

Johns Hopkins University

Code:

NCT00377078

Conditions

Clostridium Difficile

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

recombinant human lactoferrin

Study Details

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.

Conditions

Clostridium Difficile

Study ID

NCT00377078

Start date

Oct, 2005

Status verified date

Sep, 2006

Completion date

Oct, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Interventions

recombinant human lactoferrin

Primary outcome measure

  • Subjects receive 3 grams of lactoferrin in a flush solution for the automated enteric feeding system. [ Time Frame: undefined ]
  • Dosing will begin with antibiotic dosing [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

William B Greenough, III, MD

410-550-0782trigsby@jhmi.edu

Locations

Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

William B Greenough, III, M.D.

410-550-0782trigsby@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 15, 2006

Last verified

Sep, 2006

Keywords

  • recombinant human lactoferrin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2006-09-15.