跳至主要内容
临床试验/NCT05939336
NCT05939336进行中(未招募)不适用

The Prebiotic Potential of a Yeast Cell Wall Fraction Containing Mannooligosaccharides and β-glucans.

University of Florida1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Mean daily rating of gastrointestinal symptoms

研究概览

简要总结

Mannooligosaccharides (MOS) derived from baker's yeast may have prebiotic properties such as improving gastrointestinal function. The aims of this study are to determine the effect of MOS on gastrointestinal function and symptoms and fecal microbiota in older adults.

详细描述

Novel prebiotics with specific microbiome targets and without adverse gastrointestinal symptoms are needed for the exploration of health benefits. This is a 3-week, open-label pilot study designed to evaluate the effect of 15 g per day of yeast-derived mannooligosaccharides on gastrointestinal symptoms, stool frequency, fecal microbiome, and urinary metabolites.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
50 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults 50-99 years of age.
  • Able to provide written informed consent in English.
  • Willingness to complete all study procedures
  • Healthy or diagnoses with Parkinson's or multiple system atrophy

排除标准

  • Yeast allergy.
  • Self-reported kidney disease.
  • Elite athletes or long-distance runners.
  • Use of antibiotic drugs (e.g., neomycin, rifaximin) within 1 month of the screening visit.
  • Current use of laxatives or antidiarrheal medications.
  • Use of other investigational products within 3 months of the screening visit.
  • Previously or currently being treated for any intestinal disease or condition, including IBS, Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal cancer (self-report).
  • Previous gastrointestinal surgery (e.g., gastric bypass, fundoplication, bowel resection)
  • Current cancer treatment
  • Currently pregnant

结局指标

主要结局

Mean daily rating of gastrointestinal symptoms

时间窗: 14 days

Change from baseline mean sum of daily mean rating from 0 (no symptom) to 3 (severe symptoms)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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