The Six Food Elimination in Postprandial Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Duodenal eosinophilia
研究概览
简要总结
The six food elimination diet, as known in eosinophilic esophagitis, will be performed in 15 patients with functional dyspepsia (subtype postprandial distress syndrome). Screening will exclude patients with allergies by performing immunocaps on blood. Before and after the 8 weeks of diet, an gastroduodenoscopy with biopsies will be performed to evaluate duodenal eosinophilia, mast cells and permeability. To evaluate gastric sensorimotor function, a gastric emptying breath test and a barostat test will be performed before and after the diet.
Symptoms will be monitored with a daily diary (LPDS diary) and food intake will be evaluated during 2 weeks.
If there is an improvement of symptoms during the diet, a reintroduction period will start. This period will last 6 weeks. Every 2 weeks, two food groups will be reintroduced. When there is a clear worsening in symptoms, a new endoscopy with biopsies will be performed.
详细描述
To assess the effect of the six food elimination diet on duodenal eosinophilia, an interventional study will be conducted in 15 patients.
The study design includes 8 weeks of a strict 6 food elimination diet, followed by an 8 week reintroduction phase in patients with symptom improvement. The duration of 8 weeks is based on the effect of the 6 FED in eosinophilic esophagitis.
Each subject will undergo a screening before the start of the diet. During the screening visit, all study procedures will be explained, the informed consent form will be signed by the participant, and the inclusion and exclusion criteria will be checked by revising the participant's medical history and by using screening GI symptom questionnaires (Rome IV questionnaire).
The screening visit will include a physical examination, medical history and a blood sample for IgE testing to exclude typical food allergies.
When eligibility is confirmed during the screening visit, a fourteen-day period starts. In this period, the LPDS diary (Leuven Postprandial distress syndrome) and food diary will be filled out on a daily basis to assess symptoms at baseline. The food diary will be available via an application for mobile phones or online use. The Comprehensive Nutrition Assessment Questionnaire will be filled in to analyse baseline food intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Functional dyspepsia patients with meal related symptoms (Rome IV Postprandial Distress Syndrome, PDS)
- •Witnessed written informed consent prior to any study procedures
- •Patients aged between 18 and 70 years inclusive
- •Male or female patients
- •Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Women of non-childbearing potential may be included if surgically sterile or postmenopausal with at least 2 year without spontaneous menses.
- •Subject is capable to understand the study and the questionnaires, and to comply with the study requirements.
排除标准
- •History of gastrointestinal surgery (other than appendectomy).
- •Organic gastro-intestinal disease
- •Major psychiatric disorder
- •Patients with eosinophilic esophagitis
- •Presence of diabetes mellitus
- •Presence of coeliac disease, lupus, scleroderma and other systemic auto-immune disease.
- •Active H. Pylori infection or < 6 months after eradication
- •Predominant irritable bowel syndrome (IBS)
- •Predominant gastro-oesophageal reflux disease (GERD)
- •Atopic constitution or food allergy
- •Ongoing diet which interferes with the 6 food elimination diet.
- •Drugs altering gastric emptying or anti-inflammatory drugs
- •Females who are pregnant or lactating
- •Patients not capable to understand or be compliant with the study.
结局指标
主要结局
Duodenal eosinophilia
时间窗: 8 weeks
Measured with duodenal biopsies with H\&E staining
次要结局
- Symptom severity(8 weeks)
- Quality of life(8 weeks)
- Duodenal mast cells(8 weeks)
- Duodenal permeability(8 weeks)
- PDS symptoms(8 weeks)
- Functional dyspepsia symptoms(8 weeks)
- Overall symptom improvement(8 weeks)