NCT05666154招募中不适用
Targeted Elimination Diet in FD Patients Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Responder rates in targeted diet vs sham diet
研究概览
简要总结
After a thorough baseline evaluation, functional dyspepsia (FD) patients will be exposed to nutrients while undergoing confocal laser endomicroscopy (CLE). Patients presenting an acute mucosal reaction upon nutrient exposure will be instructed to exclude their respective trigger nutrient or a nutrient without mucosal reaction (=sham diet) from their diet for 4 weeks in a randomized, blinded crossover fashion.
The aim of the trial is to assess the symptomatic response to the targeted diet and further elucidate mechanisms underlying the acute mucosal reactions observed in CLE upon nutrient exposure.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-70 y/o (70 years included)
- •Male or female subjects
- •FD (PDS, EPS or overlap) according to Rome IV criteria
- •Provide written informed consent to participate in the study
- •Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
- •Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements.
排除标准
- •Pregnant or breastfeeding women
- •History of major surgery of the gastrointestinal tract (cholecystectomy and uncomplicated appendectomy are allowed)
- •Symptoms predominantly associated with irritable bowel syndrome or gastro-esophageal reflux disease
- •IgE-mediated food allergies identified by immunocaps blood tests
- •Known underlying organic gastrointestinal disease
- •Current use of NSAIDs, proton-pump inhibitors, systemic histamine-receptor antagonists, mast cell stabilizers, corticosteroids, opioids (need to be stopped at least 2 weeks). Use of antibiotics in the past 6 weeks.
- •Allergy to Fluorescein or Propofol
- •Known celiac disease
- •Following a diet, interfering with the study diet in opinion to the investigators
结局指标
主要结局
Responder rates in targeted diet vs sham diet
时间窗: After 4 weeks of dietary intervention
Response defined by an improvement of minimum 0.5 points on the LPDS scale
次要结局
- Baseline duodenal transepithelial electrical resistance between groups(At baseline)
- Baseline duodenal flux of horse-radish peroxidase between groups(At baseline)
- Evolution of duodenal flux of horse-radish peroxidase between dietary interventions(Baseline and after 4 weeks of diet)
- Evolution of duodenal transepithelial electrical resistance between dietary interventions(Baseline and after 4 weeks of diet)
- Baseline mucosal immune cell composition between groups(Baseline)
研究者
研究点 (2)
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