跳至主要内容
临床试验/NCT06028035
NCT06028035已完成不适用

A Pilot Study of Hemp Hull WFI (BB01) to Reduce Intestinal Permeability in IBS-Diarrhea With Evidence of Bile Acid Diarrhea

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年10月6日最近更新:
适应症

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
2
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

入选标准

  • 未提供

排除标准

  • 未提供

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Camilleri, MD

Principal Investigator

Mayo Clinic

研究点 (2)

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