Sucrase-isomaltase Deficiency as a Cause of Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- IBS symptom severity
研究概览
简要总结
Irritable bowel syndrome (IBS) is a functional disorder causing troublesome symptoms and reduced quality of life. It affects 10-20% of the population, hence creates large costs for society. About 30-40% of all IBS patients do not benefit from current treatment options. Sucrase-isomaltase (SI) deficiency is an unexplored condition, that may explain symptoms in IBS patients who experience no effect from today's treatments. Currently, a duodenal biopsy is the gold standard for the diagnosis of SI deficiency, however the condition is not well investigated. A 13C-labelled breath test holds promise as a non-invasive alternative, but it has not previously been validated.
This project will address the knowledge gap related to a possible association between SI deficiency and IBS by addressing two research questions that have never been answered before. We aim to:
- Validate the 13C-labelled breath test as a diagnostic tool by assessing the strength of the association between the breath test and SI activity measured in duodenal biopsies
- Use the 13C-labelled breath test in a randomized dietary crossover trial comparing a starch and sucrose reduced diet (SSRD) with the standard low-FODMAP diet in IBS patients, to evaluate whether SI activity is associated with dietary changes according to symptom severity and gut microbiota composition
详细描述
The projects includes two studies:
Study 1: Validation of the 13C-labelled breath test to diagnose sucrase-isomaltase deficiency
Background: In order to validate the 13C-sucrose breath test to diagnose SI deficiency, the test result must be compared to the "gold standard" method for diagnosis; i.e. measurements of enzyme activity from intestinal biopsies by "The Dahlquist Method", and a reference material must be established.
Objective: To compare results from the 13C-labelled breath test to enzyme activity measured in biopsies collected from the proximal small intestine in a limited patient group referred for a gastroscopic examination.
Design: A cross-sectional study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Validation of the 13C-labelled breath test to diagnose sucrase-isomaltase deficiency (n=40)
- •Inclusion Criteria:
- •Signed informed consent
- •BMI 18-30 kg/m2
- •Referred for gastroscopic examination with suspected GI disorder
排除标准
- •Unwilling or not capable of signing the informed consent
- •Sucrase-isomaltase deficiency as a cause of symptoms in patients with irritable bowel syndrome (n=80)
- •Inclusion Criteria:
- •Signed informed consent
- •BMI 18-30 kg/m2
- •IBS diagnosis according to Rome IV criteria
- •Exclusion Criteria:
- •Inflammatory bowel disease, celiac disease or diabetes mellitus
- •Chronic immune diseases affecting the GI-system
- •Unwilling/unable to maintain a stable diet throughout the study period
- •Use of antibiotic treatment for the last 4 weeks
- •Currently on a restrictive diet
结局指标
主要结局
IBS symptom severity
时间窗: 4 weeks
Symptom severity measured by the IBS-Symptom Severity Scale (IBS-SSS)
次要结局
- Quality of life in IBS(4 weeks)
- Gut microbiota composition(4 weeks)
- Fecal fermentation measured by short chain fatty acids (SCFAs)(4 weeks)