Effect of Wheat Bread and Pasta With Reduced Content of Gluten on Patients With Irritable Bowel Syndrome: Randomized Controlled Cross Over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Change of IBS severity measured by Visual analogue scale (VAS)
研究概览
简要总结
This study aim to manufacture bread and pasta with an reduced content of gluten and to assess the impact of reducing the daily intake of gluten by 50% in irritable bowel syndrome (IBS) patients. Fungal proteases and selected sourdough lactic acid bacteria will be used for making wheat bread and pasta with a reduced content of gluten (RG) (-50% of traditional products). From a technological point of view, the chemical, structural and sensory features of the RG products approached those of the bread and pasta made with normal level of gluten. The efficacy and safety of new products will be compared to traditional bread and pasta by using a double blind randomized, crossover-controlled trial in IBS patients with persistent gastrointestinal symptoms. Patients will follow two weeks of a GFD diet containing RG bread and pasta and two weeks of GFD diet containing Normal Gluten bread and pasta Symptoms severity will be assessed by Irritable Bowel Syndrome Severity Score (IBS-SS), Visual Analogue Scale (VAS), Hospital Anxiety and Depression Scale (HADS) and Irritable Bowel Syndrome Quality of Life (IBS-QoL).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •age above 18 years;
- •having bowel symptoms (altered bowel habit, lower abdominal pain, bloating, or distention suggestive of IBS), as determined by Rome III criteria.
- •Previous exclusion of CD and wheat allergy
排除标准
- •previous GI malignancy and/or surgery;
- •clinically significant cardiovascular, respiratory, endocrine, renal, hematologic or hepatic disease.
- •other clinically significant medical condition; pregnancy or lactation; alcohol abuse; drug addiction; severe neurologic or psychiatric disorders; long-term use of corticosteroids or anti-inflammatory drugs
- •participation in another clinical trial within 6 months before the onset of this trial.
研究组 & 干预措施
Reduced Gluten-Normal Gluten
干预措施: Reduced gluten bread and Pasta compared o normal gluten bread and Pasta (Dietary Supplement)
Normal Gluten-Reduced Gluten
干预措施: Reduced gluten bread and Pasta compared o normal gluten bread and Pasta (Dietary Supplement)
结局指标
主要结局
Change of IBS severity measured by Visual analogue scale (VAS)
时间窗: Two weeks of each different diet interspersed by one week of wash out. The scale will be completed ones a day.
Change of severity of IBS symptoms measured by Visual analogue scale (VAS) between reduced gluten content diet and standard gluten content diet. The 0-10 mm VAS scale (0 no pain, 10 worst possible pain) included a horizontal color gradient (green-red).
Change in Severity of IBS symptoms measured by Irritable Bowel Syndrome-Severity Score (IBS-SS)
时间窗: two weeks of each different diet interspersed by one week of wash out. The questionnaire will be completed ones a week.
Change in IBS Severity Score (IBS-SS) between reduced gluten content diet and standard gluten content diet. Mild, moderate and severe cases were indicated by scores of 75 to 175, 175 to 300 and "300 respectively. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300, and \>300, respectively.
次要结局
- Change of Quality of life scores(two weeks of each different diet interspersed by one week of wash out. The scale will be completed ones a week.)
研究者
Ruggiero Francavilla
Prof
University of Bari