Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes With Clostridium Difficile.
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Clostridium Difficile | Drug: recombinant human lactoferrin | Not Applicable |

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 |
- Subjects receive 3 grams of lactoferrin in a flush solution for the automated enteric feeding system.
- Dosing will begin with antibiotic dosing

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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.

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 ClinicalTrials.gov identifier (NCT number): NCT00377078
Contact: William B Greenough, III, MD | 410-550-0782 | trigsby@jhmi.edu |
United States, Maryland | |
Johns Hopkins Bayview Medical Center | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: William B Greenough, III, M.D. 410-550-0782 trigsby@jhmi.edu |
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 |
ClinicalTrials.gov 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 |
recombinant human lactoferrin |
Clostridium Infections Gram-Positive Bacterial Infections Bacterial Infections Lactoferrin Anti-Infective Agents |