Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes to Manage Post-Antibiotic Colonization and Infection With Clostridium Difficile
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Subjects receive 3 grams of lactoferrin in a flush solution for the automated enteric feeding system.
研究概览
简要总结
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.
详细描述
This study is a prospective, randomized, double blind, placebo controlled comparison.
Product to be tested: Lactoferrin (human) derived from rice.
Amount, dosage, route of administration, duration:Subjects will receive 3 grams of lactoferrin every 24 hours in the flush solution for the automated enteric feeding system. Dosing will begin with antibiotic dosing and continue for 8 weeks following the initial dose of antibiotic. If there is a change/adjustment in the antibiotics or initiation of another course of antibiotic therapy during the study period, blood and stool samples will be taken as an additional study point, but there will be no extension of the 8 weeks of study material administration.
Objectives: To test the use of lactoferrin (human) derived from rice in the management of post-antibiotic colonization with Clostridium difficile and the resulting inflammation reaction in the intestine in long-term care patients on enteral feeding.
Clinical Endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Subjects receive 3 grams of lactoferrin in a flush solution for the automated enteric feeding system.
Dosing will begin with antibiotic dosing
次要结局
未报告次要终点