An Open-Label Study Evaluating the Impact of Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g Twice Daily on Nutritional Status in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in epithelial barrier function, and mucosal expression of barrier-associated genes
研究概览
简要总结
To evaluate the safety and effectiveness of oral nutritional therapy Serum-Derived Bovine Immunoglobulin (SBI) on nutritional status, epithelial barrier function, and mucosal expression of pivotal genes including tight junction, secretory mechanisms, tissue repair proteins and chemokines in subjects with IBS-D.
详细描述
This is an open label study evaluating the impact of SBI 5.0 g twice daily on
- nutritional status (plasma amino acid profile and kynurenine to tryptophan ratio),
- intestinal permeability (in vivo) and
- mucosal expression of pivotal genes including tight junction, secretory mechanisms, tissue repair proteins and chemokines status in patients with IBS-D.
Plasma, duodenal and stool samples will be collected. Fifteen eligible subjects will be enrolled to receive SBI for 8 weeks (SBI 5.0g BID for 8 weeks).
Intestinal permeability will be measured in vivo by two sugar urine excretion(s) after oral ingestion.
Biopsies from the distal second or third portion of the duodenum will be obtained endoscopically, to measure mRNA expression of tight junction proteins and markers of immune function,
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female
- •IBS by Rome III criteria with predominant symptom of diarrhea
- •Baseline 14 day diary showing average of 2 days per week with >3 bowel movements per day
排除标准
- •Intake of medications that interfere with the study
- •Antibiotic within prior 2 weeks and throughout study
- •Prior abdominal surgery except appendectomy
- •Active gastrointestinal diagnosis other than IBS
- •History of allergy or intolerance to beef or to any ingredient in the investigational product
- •Uncontrolled psychiatric disorders (includes significant depression or suicidal ideation), in investigator's judgment
- •Use of tobacco products within the past six months or nonsteroidal antiinflammatory drugs or aspirin within the past week (since they all may affect intestinal permeability)
- •Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
- •For two days prior to studies, patients are instructed to avoid ingestion of artificial sweeteners such as Splenda trademark (TM) (sucralose), Nutrasweet TM (aspartame), foods containing lactulose or mannitol.
研究组 & 干预措施
Serum Bovine Immunoglobulin
Serum-Derived Bovine Immunoglobulin (SBI) 5.0 g by mouth twice daily;
Effects of SBI will be compared with observations and measurements performed at baseline PRIOR to starting the SBI treatment
干预措施: Serum-derived bovine immunoglobulin protein isolate (SBI) (Other)
结局指标
主要结局
Change in epithelial barrier function, and mucosal expression of barrier-associated genes
时间窗: 10 weeks
The primary endpoints for the study are change from baseline in mucosal expression of tight junction proteins (ZO-1, occludin, claudin)
次要结局
- Change in body measurements, amino acid metabolism, abdominal pain, and baseline stool frequency and consistency.(10 weeks)