Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes With Clostridi… (NCT00377078) | Clinical Trial Compass
UnknownNot Applicable
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Subjects receive 3 grams of lactoferrin in a flush solution for the automated enteric feeding system.