Assessing the Tolerability of Different Types of Wheat Breads in Patients With Suspected Wheat Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change of IBS-SSS Total Score
研究概览
简要总结
This study aims to assess the differences in tolerability of differently manufactured wheat breads in a target group of individuals with suspected wheat sensitivity. Additionally, it will be verified, if the absence of a response to oral exposure to defined bread types is associated with an absence of mucosal changes following CLE-assisted mucosal provocation with bread.
详细描述
Nowadays, more than 20% of people in industrialized countries suffer from a food intolerance or food allergy, with wheat and gluten intolerances on the rise. Besides the well-known conditions celiac disease and wheat allergy, another clinical entity called non-celiac wheat sensitivity (NCWS) was described, which is not yet widely understood. Resulting from inconsistent diagnostic criteria the prevalence of NCWS varies from 0.5% to 13%.
Due to the lack of validated diagnostic criteria and/or appropriate biomarkers for diagnosis of NCWS, it can currently only be suspected by exclusion of other diseases. To verify suspected NCWS, a double-blind placebo-controlled food challenge with wheat is recommended. A confocal laser endomicroscopy (CLE) with endoluminal provocation can also provide meaningful results on the individual intestinal mucosal response to specific allergens.
Furthermore, it is as yet unclear whether NCWS is triggered by gluten, FODMAPs, or other wheat components such as α-amylase trypsin inhibitors. Bread manufacturing processes can influence the composition of bread and the presence of possible triggers of intolerance reactions.
This study aims to investigate the tolerability of differently manufactured wheat breads in individuals with suspected NCWS. Additionally, we expect this approach to improve the currently inadequate diagnosis of NCWS, as well as to provide a better understanding of the underlying mechanisms.
Therefore, individuals with suspected NCWS are included in the trial. Five different types of bread will be tested, including 3 differently manufactured wheat breads, a gluten free bread and a gluten free bread with added wheat flour. Aim of this part is to test a possible psychological factor in NCWS symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 ≤75 years
- •Signed declaration of consent
- •Willingness to adhere to the prescribed diet for the duration of the study
- •Chronic gastrointestinal symptoms for at least 6 months
- •Anamnestic wheat sensitivity
- •No acute or chronic gastrointestinal diseases (e.g. celiac disease / wheat allergy)
- •No or stable medication for at least 3 months
- •No participation in another clinical trial (current or within the past 30 days)
排除标准
- •Taking intestinal therapeutics, antibiotics, immunosuppressants, anti-allergic medication or similar
- •Pregnancy / lactation
- •Occurrence of relevant diseases (possibly individual decision)
- •Revocation of consent
- •Concurrent participation in another clinical study
研究组 & 干预措施
Gluten free bread
Bread will be eaten by the participants for 7 consecutive days
干预措施: Wheat bread (Other)
Gluten free bread with added wheat flour
Bread will be eaten by the participants for 7 consecutive days
干预措施: Wheat bread (Other)
Wheat bread with Yeast, short fermentation + bread improver
Bread will be eaten by the participants for 7 consecutive days
干预措施: Wheat bread (Other)
Wheat bread with Yeast, long fermentation
Bread will be eaten by the participants for 7 consecutive days
干预措施: Wheat bread (Other)
Wheat bread with Sourdough, long fermentation
Bread will be eaten by the participants for 7 consecutive days
干预措施: Wheat bread (Other)
结局指标
主要结局
Change of IBS-SSS Total Score
时间窗: Study examinations are at baseline, after wash-out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6).
IBS-SSS (Irritable Bowel Syndrome - Severity Scoring System) Total score will be assessed with a questionnaire. Severity of gastrointestinal symptoms is shown on a scale from 0 to 500, with values from 75 - \< 175 indicating mild symptoms, 175 - 300 moderate symptoms and \> 300 severe symptoms.
次要结局
- Impairment of health-related quality of life assessed by FAQLQ-AF(Study examinations are at baseline, after wash out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6))
- Intestinal inflammation(Study examinations are at baseline, after wash-out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6))
- Intestinal permeability(Study examinations are at baseline, after wash out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6))
- Metabolic alterations(Study examinations are at baseline, after wash-out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6))
研究者
Stephan C. Bischoff, MD, Professor
Professor Dr. med.
University of Hohenheim