跳至主要内容
临床试验/NCT02085889
NCT02085889Unknown不适用

Fructose and Lactose Intolerance and Malabsorption: the Relationship Between Metabolism and Symptoms in Functional Gastrointestinal Disorders

Brain-Gut Research Group1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
3,000
试验地点
1
主要终点
Number with adequate symptom relief

研究概览

简要总结

Background: The association of fructose and lactose intolerance and malabsorption with the symptoms of different functional gastrointestinal disorders (FGID) is unclear. The mechanisms behind the multi-organ symptoms remain unclear. Both FGID and saccharide intolerances are common (>10% of any given population). Dietary modification based on intolerance diagnostics could provide an effective treatment for FGID, which are otherwise difficult to treat.

Aim: To investigate the prevalence and interrelationships of fructose and lactose intolerance (symptom induction) and malabsorption (breath test gas production) and their association with clinical GI as well as non-GI symptoms in FGID and the outcome of standard dietary intervention. Mechanisms related to symptom genesis will be investigated using metabolomic analysis of plasma and urine by gas chromatography/time-of-flight mass spectrometry (GC/TOFMS).

Methods: Fructose and lactose intolerance (defined by positive symptom index) and malabsorption (defined by increased hydrogen/methane) will be determined in successive male and female FGID patients in a single center using breath-testing. Symptoms will be recorded using standardised questionnaires and the Rome III criteria. The prevalence of the intolerances in the different FGID subgroups and the associations between breath testing results, clinical symptoms and the outcome of dietary modification will be assessed. Factors predictive of the outcome of dietary modulation will be screened for. GC/TOFMS will be used to assess the human and microbial metabolome in urine and plasma.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number with adequate symptom relief

时间窗: 6-12 weeks

adequate symptom relief in response to reduction of fermentable sugars

次要结局

  • Association between adequate symptom relief and test variables(6-12 weeks)

研究者

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

Clive H Wilder-Smith, MD

Principle Investigator

Brain-Gut Research Group

研究点 (1)

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