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临床试验/NCT02946827
NCT02946827Unknown不适用

The Efficacy of a Low FODMAPs (Fermentable Oligo- di- and Monosaccharides and Polyols) Diet in Celiac Patients With Persistent Gastrointestinal Symptoms

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
68
试验地点
2
主要终点
Improvement of VAS (psychometric response scale level continuous line between two end-points 0-10) values of globel well-being in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients in balanced gluten free diet.

研究概览

简要总结

FODMAPS (fructose, oligosaccharides, monosaccharides, disaccharides and polyols) are characterised as fermentable but poorly absorbed carbohydrates which enter the colon and are utilised by colonic bacteria. During fasting colonic nutrients are scarce but ingesting FODMAPS causes a rapid increase in carbohydrate which can overwhelm the microbiota's ability to utilise substrate. The excess reducing equivalents will generate hydrogen or methane. The principal symptoms are diarrhoea and abdominal distension. Patients with irritable bowel syndrome appear to benefit by restricting intake, possibly because they are hypersensitive to intestinal distension.

The focus of the study is to evaluate if in celiac patients with persistent abdominal symptoms and with a correct gluten free diet, a low FODMAPs diet can improve their symptoms. Moreover the study would like to observe if a dietary restriction in FODMAPs carries the risk of nutritional inadequacy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

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

  • Celiac patients assessed through positive serology and histology
  • functional patients according IBS Roma III criteria
  • subjects with VAS>5

排除标准

  • refractory celiac disease
  • disaccharide intolerance (fructose an lactose breath test)
  • abdominal surgery
  • comorbidity
  • patients recruited in other clinical trials
  • positive patients at lactulose breath test (SIBO)

结局指标

主要结局

Improvement of VAS (psychometric response scale level continuous line between two end-points 0-10) values of globel well-being in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients in balanced gluten free diet.

时间窗: 21 days

次要结局

  • Improvement of VAS values of IBS symptoms in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet.(21 days)
  • Improvement of psychological problems and symptoms of psychopathology through the symptom checklist 90 R (SCL 90 R) in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet.(21 days)
  • Evaluation of the dietary intake in micro and macro-nutrients before and after a Low FODMAP diet or a balanced Gluten Free diet through questionnaire.(21 days)
  • Improvement of quality of life assessed through SF-36 questionnaire (eight scale scores) in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet.(21 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leda Roncoroni

BS PhD

University of Milan

研究点 (2)

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