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临床试验/NCT03678935
NCT03678935已完成不适用

Effect of Fermentable Oligo-, di-, and Monosaccharides and Polyols (FODMAP) Restriction on Persistent GI-symptoms in Coeliac Patients

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Change in gastrointestinal symptoms

研究概览

简要总结

The first aim of the study is to investigate the prevalence of persistent gastrointestinal symptoms and compliance with gluten-free diet and the intake of FODMAP in adult celiac patients.

A web-based survey wil be performed and thereafter a randomized controlled trial to test the effect of a FODMAP reduction in patients with celiac disease with irritable bowel-like symptoms.

详细描述

Effect of FODMAP reduction in patients with celiac disease. Celiac disease is an immune-mediated disease that causes damage to the intestines. The condition affects 1-2% of the population, and the incidence is increasing. Treatment with gluten-free diet usually produces good results, yet there are many patients who have persistent gastrointestinal symptoms. Studies indicate that this applies to as many as 20%, but the situation in Norway in unknown. Nor is it known why somebody has persistent gastro- intestinal complaints. It may be due to difficulty following the diet or what is called irritable bowel syndrome (IBS), which is a fairly common condition in the population.

It has been shown that people with IBS can benefit from a diet with reduced FODMAP content. The term FODMAP is an acronym for: Fermentable Oligo, Di-, Monosaccharides and Polyols. It is a type of carbohydrate that is not absorbed in the large intestine, but continues to the colon where they are fermented by the bacteria. Example of foods with a high content of FODMAP is wheat, onion, garlic, parsley, apples, pears, mango, beans, honey and milk. It is not known whether celiac patients with persistent symptoms will have the beneficial effect of low FODMAP diet.

In this study, investigators want to study the prevalence of persistent gastrointestinal symptoms and compliance with gluten-free diet and the intake of FODMAP in adult celiac patients. Members of the Norwegian coeliac organization will be invited to participate in the study. A web-based questionnaire is used to make it easy for members to respond.

Participants who report persistent gastrointestinal intestinal symptoms will then be invited to a randomized and controlled study. They will be divided into two groups where one group will be advised to reduce the intake of FODMAP and the other group will be advised to follow a strict gluten-free diet. Participants will record stomach and intestinal complaints before and after four weeks with study sites. Investigators will find out whether there is a difference between gastric and intestinal complaints between the two groups. Blood- and feces samples will also be collected.

The results will provide new knowledge about how to adapt dietary advice to celiac patients with persistent gastrointestinal complaints, and hopefully help them to a better quality of life.

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Coeliac disease
  • Adherent to GFD for at least 12 months
  • Strictly adherent to GFD
  • Normal coeliac disease (CD) serology and duodenal biopsy (Marsh 0-1)
  • Persistent GI-symptoms defined by GSRS-IBS score of 30 or more
  • Living less than 2 hour from study centre

排除标准

  • Pregnancy or lactating women
  • Use of immunomodulating drugs in the last 3 months
  • Use of anti-inflammatory drugs in the last 3 months
  • Use of antacid drugs in the last 2 months
  • Ongoing infection (mild infection such as upper airway infection is ok)
  • Other chronical bowel disorder (except for IBS)
  • Previous tried the LFD with guidance of a dietician

研究组 & 干预措施

Low FODMAP diet (LFD)

Active Comparator

The LFD wil receive advice on how to follow a low FODMAP diet. They wil follow this diet for 4 weeks. Thereafter they receive advice on how to reintroduce high FODMAPs again.

干预措施: Low FODMAP diet (Other)

Control

No Intervention

Control group. Participants follow their regular gluten-free diet (GFD), with no changes to their diet. They wil receive the same dietary advice as the LFD-group after the 4-week study.

结局指标

主要结局

Change in gastrointestinal symptoms

时间窗: 4 weeks

Measured by score in gastrointestinal symptom rating scale for irritable bowel syndrome (GSRS-IBS). The scoring is based on a 7-grade Likert scale in which 1 point indicates no symptoms and 7 points the most severe gastrointestinal symptoms. The total score in the gastrointestinal symptom rating scale for irritable bowel syndrome is calculated as a mean value of all 13 items. The maximum score is 91 and the minimum score is 13. A higher score means more severe symptoms. A score higher than 1 standard deviation (SD, 0.66 points) compared to the control mean are considered to have increased gastrointestinal symptoms.

次要结局

  • Changes in biomarkers like faecal microbiota(4 weeks)
  • Quality of Life in patients with coeliac disease: Short form- 36 (SF-36)(4 weeks)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Knut E. A. Lundin

Professor medicine

Oslo University Hospital

研究点 (2)

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