Effects of Traditional and Low-FODMAP Rye Bread in Irritable Bowel Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Change is IBS symptoms by using IBS-SSS questionaire
研究概览
简要总结
The purpose of this study is to evaluate if low-FODMAP (Fermented Oligo-, Di-, Monosaccharides And Polyols) rye bread is better tolerated in irritable bowel syndrome than commonly available traditional rye bread higher in FODMAP carbohydrates. The study also aims to investigate patients' compliance to rye bread regimen, potential changes is gut microbiota and hydrogen production during the test periods (a marker of large bowel fermentation of poorly absorbed carbohydrates).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBS according to Rome III criteria. Accepted sub-types include IBS-M, IBS-D and IBS-U
- •Age 18-65 years
- •Willing to use rye bread daily during the study periods
排除标准
- •IBS-C (constipation dominant)
- •Celiac disease
- •Major gastrointestinal operations like bowel gastric resection
- •Non-treated hypo- or hyperthyroidism
- •Alcoholism, severe depression, dementia, cancer or other diseases likely to severly impair the participants ability to conclude the protocol
- •Regular (almost daily) use of NSAIDs, antibiotics or lactulose
- •Linaclotide and other prescription medicines targeted specifically to IBS
- •Pregnancy and lactation
- •Follows currently strict low-FODMAP diet
研究组 & 干预措施
Traditional rye bread
As part of habitual diet participants are expected to consume 100-200 grams of traditional Finnish rye bread daily
干预措施: Traditional Finnish rye bread (Other)
Low-FODMAP rye bread
As part of habitual diet participants are expected to consume 100-200 grams of low-FODMAP rye bread daily
干预措施: Low FODMAP rye bread (Other)
结局指标
主要结局
Change is IBS symptoms by using IBS-SSS questionaire
时间窗: 4 weeks
次要结局
- IBS quality of life by using IBS QoL questionnaire(4 weeks)
- Changes in specific IBS symptoms measured by 100 mm VAS scale(4 weeks)
- Changes is intestinal microbiota evaluated by fecal samples(4 weeks)
- Changes in hydrogen excretion evaluated by 6 hours breath test after standard rye bread breakfast(4 weeks)