NL-OMON52898已完成不适用
The effects of the different bread types of fully known composition on gastrointestinal symptoms in individuals with non-coeliac wheat sensitivity. - Different bread types in NCWS.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Study A and B
- •- Develops self-reported GI symptoms within 12 hours after a single intake of
- •- Aged between 18-70 years;
- •- Asymptomatic or mildly symptomatic (overall symptoms score with VAS below or
- •equal to 30 mm) while on their symptom-free diet;
- •- Must have a freezer (-18ºC) to store the study breads during the study.
- •Follow-up measurement
- •- (1) NCWS subject: develops GI symptoms within 12 hours after consumption of
- •at least one of the study breads of study A or B (+15 mm on VAS); OR (2)
- •Healthy control (sex matched to NCWS subjects): eats bread regularly (min. 5
- •days per week)
- •- Age between 18-70 years;
- •- Must have a fridge (4-7ºC) to shortly store the collected faecal sample.
排除标准
- •Study A and B
- •- Medical history of coeliac disease, wheat allergy, presence of an organic
- •gastrointestinal (GI) disease (such as inflammatory bowel disease) or other
- •disease which may interfere with NCWS symptoms (upon judgment of the
- •physician-clinical investigator (prof. Keszthelyi, Gastroenterologist MUMC+/
- •prof. Witteman, PI and consulting gastroenterologist WUR));
- •- Previous major abdominal surgery or radiotherapy interfering with
- •gastrointestinal function;
- •- Use of medication potentially influencing gastrointestinal function and/or
- •NCWS symptoms is allowed, provided that dosing has been stable for * 1 month
- •before enrolment;
- •- Administration of probiotic, prebiotic supplements, investigational drugs or
- •participation in any scientific intervention study, which may interfere with
- •this study (to be decided by the principle investigator), in the 14 days prior
- •to the study.
- •Follow-up measurement - in addition to the criteria listed above:
- •- Use of antibiotics during the 6 past months prior to faecal sampling;
- •- Healthy controls: developing GI symptoms after consumption of bread, or
- •following a gluten-free or wheat-free diet.
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