NCT07089498已完成不适用
13C-Octanoic Acid Breath Test for the Evaluation of a Low-fodmaps Diet on Gastric Emptying in Celiac Patients With Functional Disorders
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico4 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2021年2月3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
- 68
- 试验地点
- 4
- 主要终点
- Evaluating gastric emptying time by a 13C-Octanoic Acid Breath Test, pre and post-diet (T1 and T2) in celiac patients with functional dyspepsia and non-celiac patients with functional dyspepsia
研究概览
简要总结
The goal of this interventional study is the evaluation of a diet low in fodmaps on gastric emptying in celiac patients with functional disorders.
详细描述
The goal of this interventional study is the evaluation of a diet low in fodmaps on gastric emptying in celiac patients with functional disorders.
The aims of the study are:
- Evaluation of gastric emptying time by a 13C-Octanoic Acid Breath Test, pre and post-diet (T1 and T2) in celiac patients with functional dyspepsia and non-celiac patients with functional dyspepsia.
- Evaluation of gastrointestinal symptoms, quality of life, and mental health in patients with non-celiac and celiac functional disorders pre- and post-diet (T1 and T2).
Participants:
- Will run the 13C-octanoic acid breath test pre- and post-diet
- Will complete the VAS, SF-36, and SCL-90 questionnaires pre- and post-diet
- Will follow a low fodmap gluten free diet or a regular gluten-free diet for six weeks Researchers will compare celiac and non-celiac patients.
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
- 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
- 否
入选标准
- •age: ≥ 18 years old
- •gender: male or female
- •patients who have signed informed consent
- •patients diagnosed with a functional gastrointestinal disorder who meet Rome IV criteria (according to Rome Foundation's latest revision of 2016)
排除标准
- •patients who have not given informed consent
- •patients without a diagnosis of a functional gastrointestinal disorder
结局指标
主要结局
Evaluating gastric emptying time by a 13C-Octanoic Acid Breath Test, pre and post-diet (T1 and T2) in celiac patients with functional dyspepsia and non-celiac patients with functional dyspepsia
时间窗: Six weeks
Evaluating gastric emptying time by a 13C-Octanoic Acid Breath Test, pre and post-diet
次要结局
- Comparison of the effects of dietary recommendation for a diet low in Oligo-, Di- and Monosaccharides and Polyols (FODMAPs) or a balanced diet in celiac and non-celiac dyspeptic patients on gastric emptying time(Six weeks)
- Evaluation of gastrointestinal symptoms (VAS)(Six weeks)
- Evaluation of quality of life (SF-36)(Six weeks)
- Evaluation of mental health (SCL-90)(Six weeks)
研究者
研究点 (4)
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