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临床试验/NCT05688826
NCT05688826已完成不适用

Comparison of Sugar Load Between Normal and Functional Variants of Sucrase-isomaltase Genes in IBS

Region Skane2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
40
试验地点
2
主要终点
Changes from baseline of blood glucose levels

研究概览

简要总结

The investigators know that many patients with irritable bowel syndrome (IBS) have functional variants of genes coding for sucrase-isomaltase enzymes. The investigators will now examine whether these functional variants are associated with defect degradation of sucrose and associated gastrointestinal symptoms

详细描述

The investigators have in a previous study included IBS patients for treatment with a starch- and sucrose reduced diet (SSRD). The investigators found a great improvement of symptoms. The investigators gene-tested those patients, and now have the full identification of all functional variants encoding sucrase-isomaltase enzymes.

The investigators will invite patients from this previous study with normal genes and functional variants of genes. The patients will come fasting over night to the department of clinical research. The participants will ingest 75 g sugar dissolved in 0.8 dl water and flavored with lemon, to ingest during 5 minutes. After that, glucose will determined repeatedly up to 2 hours afterwards. At the same time, the participants have to assess their gastrointestinal sympotms on visual analogue scales (VAS).

The investigators will compare the raise in b-glucose and symptoms between the groups of patients, divided into gene expression.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Participants of our previous clinical trial with SSRD diet (NCT03306381)

排除标准

  • Difficulties in taking blood samples

结局指标

主要结局

Changes from baseline of blood glucose levels

时间窗: From distribution repeatedly up to 2 hours

Measurement of glucose levels in blood drawn from an intravenous needle and analyzed at the Department of Clinical Chemostry

Change from baseline of gastrointestinal symptoms

时间窗: From baseline and up to 2 hours, at the same time points as blood glucose is measured

Measurment of gastrointestinal symptoms on a visual analog scale measuring symptoms, range 0-100 mm, repeatedly at the same time points as blood glucose is measured. The higher scores, the worse symptoms.

次要结局

未报告次要终点

研究者

发起方
Region Skane
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bodil Ohlsson

Professor

Region Skane

研究点 (2)

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