A Pilot Study of Hemp Hull WFI (BB01) to Reduce Intestinal Permeability in IBS-Diarrhea With Evidence of Bile Acid Diarrhea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in urinary excretion of 13^C-mannitol
研究概览
简要总结
The purpose of this study is the effect of a study bar, which contains 15 grams of insoluble dietary fiber total sourced from Hemp hulls, on intestinal permeability in irritable bowel syndrome (IBS)-bile acid diarrhea individuals.
详细描述
Patients with irritable bowel syndrome-bile acid diarrhea (IBS-BAD) have no evidence of significant histologically-evident inflammation or ulceration. The condition is often unrecognized in comparison with natural variations in bowel function in the general population. Hemp seeds are a complete source of protein, providing all nine essential amino acids, as well as polyunsaturated fats, especially omega-3 fatty acid, fiber, minerals and vitamins. Hemp hulls, the outer shell of the seeds, are typically rich in dietary fiber and phenolics and showed to have a beneficial effect on gut barrier function in vitro.
To demonstrate reduced intestinal permeability after 3 weeks of BB01 (20g of BB01, which reflects 15g of insoluble dietary fiber) consumption in a group of 10 patients with IBS-diarrhea with evidence of bile acid diarrhea, a group that has been previously documented to have increased GI permeability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior diagnosis of bile acid diarrhea as documented by either
- •total bile acid in 48 hour stool excretion of 2337 micromoles per 48 hours, or
- •greater than 1000 micromoles per 48 hours with greater than 4% primary bile acids in stool, or
- •greater than 10% primary bile acid (CA and CDCA) in stool 48 hour collection, or
- •serum 7 alpha C4 greater than 52 ng/mL
- •BMI <40 kg/m
- •Prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study.
- •Participants receiving bile acid sequestrant will not be permitted to continue therapy. and need to stop one week before baseline test.
- •No use of oral antibiotics and NSAIDs for 2 weeks prior to study treatment
排除标准
- •Diabetes mellitus (type 1)
- •Diabetes mellitus type 2 if taking metformin or GLP-1 agonist treatment (exenatide, liraglutide, semaglutide)
- •Uncontrolled hypertension (with BP measured >140/90mmHg in the CRTU)
- •BMI ≥40 kg/m2
- •Chronic NSAID use (>1 day/week)
- •Use of oral antibiotics and NSAIDs for 2 weeks prior to and during the entire 21 day study period
- •Use of bile acid sequestrant for 1 week prior to and during the entire 21 day study period
- •Diagnosis of gastrointestinal diseases that are associated with inflammation such as inflammatory bowel diseases and celiac disease or gastrointestinal infection in the prior 4 weeks;
- •Prior intestinal or colonic resection; note prior cholecystectomy, appendectomy, and tubal ligation or hysterectomy will all be permissible for participation in the study
- •Participation in highly vigorous exercise such as running >5 miles per day in week prior to the permeability test
研究组 & 干预措施
BB01 Supplement Bars
Subjects will consume two BB01 supplement bars daily for 21 days.
干预措施: BB01 (Dietary Supplement)
结局指标
主要结局
Change in urinary excretion of 13^C-mannitol
时间窗: Baseline, 3 weeks
Percent urinary excretion of 13\^C-mannitol
Change in urinary excretion of lactulose
时间窗: Baseline, 3 weeks
Percent urinary excretion of lactulose
次要结局
未报告次要终点
研究者
Michael Camilleri, MD
Principal Investigator
Mayo Clinic