A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Impact of Serum-derived Bovine Immunoglobulin/Protein Isolate (SBI) on Clostridium Difficile (C. Difficile) Infection (CDI) in Hospitalized Ulcerative Colitis (UC) Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Time (# of days) to resolution of diarrhea
研究概览
简要总结
The effects of serum-derived bovine immunoglobulin/protein isolate (SBI) will be evaluated and compared to matching placebo in two distinct patient populations:
I. Hospitalized ulcerative colitis (UC) patients who tested positive for Clostridium difficile (C. difficile) at time of admission and are receiving vancomycin.
II. Hospitalized UC patients who tested negative for C. difficile at time of admission.
详细描述
The effects of serum-derived bovine immunoglobulin/protein isolate (SBI) will be evaluated and compared to matching placebo in two distinct patient populations:
I. Hospitalized ulcerative colitis (UC) patients who tested positive for Clostridium difficile (C. difficile) at time of admission and are receiving vancomycin.
Primary Objective:
• To evaluate the effect of SBI on time (# of days) to resolution of diarrhea, defined as a consecutive 24 hour period with only formed bowel movements (Bristol Stool Scale (BSS) ≤ 4) in this patient population
Secondary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of UC confirmed by colonoscopy and histology.
- •Confirmed active UC upon hospital admission, defined by a partial Mayo Score of ≥ 3 with a stool frequency subscore of ≥
- •Concomitant therapy for UC will be permitted. Subjects will be instructed not to make any medication changes after hospital discharge before first discussing with the Investigator.
- •Eligible subjects will be assigned to one of two different and independent patient groups based on C. difficile status as determined by clinical symptoms with diarrhea and laboratory tests: either a polymerase chain reaction (PCR) assay or glutamate dehydrogenase (GDH) screening test used in two- or three-step algorithm with subsequent toxin A and B EIA testing.
排除标准
- •Subjects with history of constipation within a week of the screening visit; or any serious hepatic, renal, cardiovascular, neurological or hematological disorder in the opinion of the Investigator.
- •Subjects with history of drug or alcohol abuse, history of psychiatric disorders, known allergy or hypersensitivity to beef or any component of SBI.
- •Subjects with a history of antibiotic treatment within the 4 weeks prior to enrollment.
- •Subjects using anti-diarrheal medications (e.g., loperamide and bismuth subsalicylate).
- •Note: anti-diarrheal medications will be prohibited throughout the study.
- •Subjects who have been admitted to the hospital more than 48 hours prior to enrollment.
- •Women who are pregnant.
结局指标
主要结局
Time (# of days) to resolution of diarrhea
时间窗: 12 weeks
Group 1 \& Group 2 subjects: Stool consistency will be assessed using the BSS. Subjects will be provided a daily diary A to record the time and consistency of each bowel movement in a 24 hour period. At the Week 4 visit, the Investigator will calculate the time (# of days) to resolution of diarrhea, defined as a consecutive 24 hour period with only formed bowel movements (BSS ≤ 4), after initiation of investigational product (Day 1).
次要结局
- Nutritional Status measured by pre-albumin(12 weeks)
- Safety and Tolerability evaluated by reported and observed treatment related adverse events(12 weeks)
- Incidence of recurrent CDI(12 weeks)
- UC status measured by P-SCCAI(4, 8 and 12 weeks)
- UC status measured by CRP(12 weeks)
- Nutritional Status measured by albumin(12 weeks)
- Nutritional Status measured by hand grip strength(12 weeks)
- Fecal Microbiome(12 weeks)
- Incidence of C. difficile(12 weeks)
- UC status measured by BSS(4 weeks)
- UC status measured by Fecal calprotectin(12 weeks)
- UC status measured by colectomy rate(12 weeks)
- Length of Hospitalization(12 weeks)
- Quality of Life evaluated using the SF-36(12 weeks)
- Nutritional Status measured by fecal alpha-1 antitrypsin(12 weeks)
研究者
Stephen Hanauer
Professor of Medicine
Northwestern University