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临床试验/NCT01483287
NCT01483287已完成早期 1 期

The Effects of Added Enzyme α-Galactosidase at a Carbohydrate-rich Meal in IBS

Sahlgrenska University Hospital, Sweden2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年11月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Change in symptoms

研究概览

简要总结

IBS (irritable bowel syndrome) is a functional gastrointestinal disorder which is characterized by recurrent pain and/or discomfort, altered stool form, and abdominal distension. It has been established that food items such as beans, peas, lentils, peppers, and onions can increase gas production. What these have in common is that they all contain large amounts of complex carbohydrates. The enzymes in the small intestine are not able to fully digest these large molecules, which in turn are fermented by the colonic microflora. This fermentation is conducted through the production of short chain fatty acids and gases such as hydrogen and methane. Alpha-Galactosidase is an enzyme that has the ability to break down these indigestible carbohydrates to galactose and sucrose in the small intestine and to facilitate the absorption and minimize the gas production from bacteria in the colon.

The aim of this study is to assess if the gastrointestinal symptoms, above all problems from gas and distension, is alleviated when the enzyme α-Galactosidase (present in Nogasin capsules) is ingested with food.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Patients diagnosed with Irritable Bowel Syndrome(IBS), (in accordance with ROME III criteria), and
  • With the specific symptoms of bloating and/or abdominal distension.

排除标准

  • The patients should not have any other gastrointestinal diseases such as IBD or celiac disease.

结局指标

主要结局

Change in symptoms

时间窗: 24 hours

Symptom questionnaire are filled in each half hour during trial (hours 0800-1530),four times between hours 1700-2000, once at bedtime, once at following morning before breakfast. Changes between visit 1 and visit 2 are registered.

次要结局

  • Changes in expiration air(24 hours)

研究者

发起方
Sahlgrenska University Hospital, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Magnus Simrén

Clinical Professor

Sahlgrenska University Hospital, Sweden

研究点 (2)

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