A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Pilot Study Evaluating Serum-Derived Bovine Immunoglobulin / Protein Isolate in the Dietary Management of Mild to Moderate Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 13
- 主要终点
- Change in Crohn's Disease Activity Index (CDAI)
研究概览
简要总结
The objective of this study is to evaluate the nutritional therapy with SBI (a medical food) as compared to placebo in the clinical dietary management of mild to moderate Crohn's disease.
详细描述
This is a randomized, double-blind, placebo-controlled, multi-center, pilot study evaluating SBI 10 g BID compared to matching placebo for 12 weeks followed by a 12 week open-label extension SBI 10 g BID (EnteraGam) in the dietary management of mild to moderate Crohn's disease.
The effect of SBI will be evaluated on Crohn's disease related symptoms and inflammation symptom control as measured by Crohn's disease activity index (CDAI) scores and plasma and stool markers of inflammation. The patient's quality of life will also be assessed as an indicator of disease state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Confirmed diagnosis of mild to moderate Crohn's disease for at least 3 months.
- •Screening CDAI between >150 and ≤ 250 based on subject recall.
- •Average of greater than two liquid or soft stools per day and an abdominal pain intensity score >
- •Subject has at least one positive biomarker of inflammation: fecal calprotectin >100 µg/g; elevated C-reactive protein (CRP) >2 mg/dL.
排除标准
- •Positive stool test for pathogenic bacteria including Clostridium difficile or O&P.
- •Confirmed intestinal stricture with obstructive-like clinical symptoms.
- •Bowel resection within the previous 6 months.
- •Change in medical therapy: must have been on a stable dose of
- •corticosteroids (prednisone or prednisolone) less than or equal to 20 mg per day for 2 weeks prior to screening,
- •budesonide less than or equal to 9 mg per day for 2 weeks prior to screening,
- •5-aminosalicylates for 2 weeks prior to screening, and
- •immunomodulators for 6 weeks prior to screening.
- •Taking greater than 20 mg per day of a corticosteroid (prednisone or prednisolone) or greater than 9 mg of budesonide.
- •Received biologic therapy in past 2 years.
- •Diagnosis of one or more co-morbid condition (s) requiring medical or surgical therapy that may affect bowel function, gastrointestinal symptoms.
- •Serious infection in the 3 months prior to enrollment.
- •Allergy or intolerance to beef or to any ingredient used in the product.
- •Participated in an investigational drug or device study within 30 days.
- •Does not have access to the internet.
- •Taken EnteraGam®
研究组 & 干预措施
SBI 10 g BID
Serum-derived Bovine Immunoglobulin / Protein Isolate (SBI) 10.0 grams twice per day
干预措施: Serum-derived Bovine Immunoglobulin / Protein Isolate (Other)
Placebo BID
Placebo w/control protein
干预措施: Placebo (Other)
结局指标
主要结局
Change in Crohn's Disease Activity Index (CDAI)
时间窗: 12 weeks
Change in abdominal pain intensity score
时间窗: 12 weeks
Change in the number of liquid and soft stools
时间窗: 12 weeks
Change in C-reactive protein (CRP)
时间窗: 12 weeks
Change in plasma albumin levels
时间窗: 12 weeks
Change in body mass index
时间窗: 12 weeks
Change in Quality of Life (SF-36)
时间窗: 12 weeks
Change in fecal calprotectin
时间窗: 12 weeks
Change in weight
时间窗: 12 weeks
次要结局
- Clinically significant changes from baseline in laboratory testing(12 and 24 weeks)
- Assess the incidence of adverse events (AEs) and serious AEs (SAEs)(12 and 24 weeks)
- Measure clinically significant changes from baseline in vital signs(12 and 24 weeks)