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临床试验/NCT03269032
NCT03269032已完成不适用

Impact of the Mediterranean Diet on the Gut Microbiome and Symptoms of Diarrhea-Predominant Irritable Bowel Syndrome

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Phase 1- Change in predominant enterotypes and diversity of fecal microbiota

研究概览

简要总结

This study will evaluate the impact of a Mediterranean-style diet on microbiome diversity compared to a typical American diet. The study will observe the microbiome composition comparisons in healthy volunteers as well as in patients with Irritable Bowel Syndrome with Diarrhea (IBS-D) to see if the consumption of a Mediterranean-style diet has a positive effect on improving symptoms of IBS-D.

详细描述

Irritable bowel syndrome (IBS) is the most prevalent and well-studied functional gastrointestinal disorder. While IBS has no direct mortality, it does compromise quality of life, incurs morbidity, and has a substantial economic impact on society. The gut microbiome may play a significant role in the pathogenesis of IBS. Even though the exact mechanisms underlying this relationship have not been presented, it is suggested that certain microorganisms may increase gut permeability, activate the mucosal immune response, increase visceral sensitivity and alter intestinal motility via a bidirectional brain-gut interaction. Recent studies suggest that the salutary impact of the Mediterranean diet may be due to its effects on the composition of the gut microbiome. In a recent cohort study in Italy, subjects who adhered most closely to a classical Mediterranean diet had more favorable bacterial enterotypes (e.g., Prevotella) in their stool, as well as higher levels of short-chain fatty acids - which are essential for colonic function. Studies have also showed that diet alters the predominant microbiome enterotypes and that microbiome composition can change quickly, within 24 hours, after a dietary intervention. Therefore, consumption of a Mediterranean diet may ameliorate the gut dysbiosis associated with IBS-D.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • must be willing to eat pre-prepared foods for 4 weeks
  • subjects must have no medical, religious, or cultural dietary restrictions that would preclude their eating a Mediterranean diet.
  • Phase 2 subjects- must have diagnosis of IBS based on Rome III criteria and have diarrhea-predominant disease, defined as >50% of bowel movements characterized as diarrhea

排除标准

  • history of gastrointestinal disease, including celiac disease, inflammatory bowel disease, or lactose intolerance
  • diabetes mellitus
  • congestive heart failure
  • coronary artery disease
  • chronic liver disease or end stage renal disease
  • pregnancy or breastfeeding
  • trainees under the direct supervision of the PI and patients receiving direct ongoing medical care from the PI or Co-I will not be enrolled as subjects in this study

结局指标

主要结局

Phase 1- Change in predominant enterotypes and diversity of fecal microbiota

时间窗: Baseline, 2 weeks, 4 weeks

Fecal microbiota diversity and enterotypes will be determined through bacterial 16S rRNA gene sequences on stool samples collected from the healthy volunteer participants in phase 1.The data will initially be analyzed by calculating descriptive statistics and plotting to examine for potential outliers and the necessity for data transformation.

Phase 2-Change in predominant enterotypes and diversity of fecal microbiota

时间窗: Baseline, 2 weeks, 4 weeks

Fecal microbiota diversity and enterotypes will be determined through bacterial 16S rRNA gene sequences on stool samples and rectal biopsies performed on the subjects with IBS-D in phase 2.The data will initially be analyzed by calculating descriptive statistics and plotting to examine for potential outliers and the necessity for data transformation.

次要结局

  • Changes in plasma inflammatory marker - Erythrocyte sedimentation rate (ESR)(Baseline, 2 weeks, 4 weeks)
  • Changes in plasma inflammatory marker - C-reactive protein (CPR)(Baseline, 2 weeks, 4 weeks)
  • Changes in IBS Symptom Severity Scores(Baseline, 2 weeks, 4 weeks)
  • Changes in Hospital Anxiety and Depression Scores(Baseline, 2 weeks, 4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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