Effects of Wheat Breads on Symptoms of IBS, a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Subjective symptoms using visual analog scale (VAS) daily
研究概览
简要总结
This is randomized pilot study comparing tolerability of yeast-baked wheat bread and sourdough wheat bread in irritable bowel syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBS & subjective sensitivity to wheat
排除标准
- •celiac disease, pregnancy, lactation, IBD, major GI operations
研究组 & 干预措施
Fermented wheat bread for 7 days
Long sourdough fermentation
干预措施: Sourdough wheat bread (Other)
Fermented wheat bread for 7 days
Long sourdough fermentation
干预措施: Gluten-free diet (Other)
Yeast baked wheat bread for 7 days
Regular toast bread
干预措施: Regular yeast baked toast bread (Other)
Yeast baked wheat bread for 7 days
Regular toast bread
干预措施: Gluten-free diet (Other)
Run-in
Gluten-free diet for 7 days before entering either bread period
干预措施: Gluten-free diet (Other)
结局指标
主要结局
Subjective symptoms using visual analog scale (VAS) daily
时间窗: 7 days
Self-reports of bloating, dyspepsia, constipation, diarrhoea, abdominal pain, borborygmi, flatulence, heart burn, urgency to defecate, incomplete feeling of defecation, abdominal cramps, tiredness, skin rash, mood, nausea, joint pain, ability to concentrate and loss of appetite on VAS 0-100. Participants fill in VAS questionnaires at the end of each day
次要结局
未报告次要终点