THE EFFECT OF DIETARY SUPPLEMENTATION WITH PALMITOYLETHANOLAMIDE ON GASTROINTESTINAL SYMPTOMS IN FUNCTIONAL DYSPEPSIA PATIENTS.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effect (change) on the Leuven-postprandial distress scale (LPDS) (0-15), higher score indicating more symptoms)
研究概览
简要总结
The goal of this placebo controlled randomized double blind interventional study is to assess the effect of palmitoylethanolamide supplementation in patients with functional dyspepsia The main questions it aims to answer are:
- The efficacy of PEA on functional dyspepsia symptoms measured using the LPDS questionnaire
- The effect of PEA on duodenal mucosal permeability.
Participants will receive an 8-week during treatment with PEA 3x400 mg per day or placebo 3 times per day.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with functional dyspepsia as diagnosed by the Rome IV criteria.
- •Subjects must provide witnessed written informed consent prior to any study procedures being performed.
- •Subjects aged 18-70 years old.
- •Male or female subjects.
- •Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements.
- •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.
排除标准
- •Presence of a history of gastrointestinal surgery other than appendectomy and cholecystectomy.
- •Organic gastro-intestinal disease
- •Major psychiatric disorder such as major depression
- •Presence of coeliac disease, lupus, scleroderma and other systemic auto-immune disease.
- •Patients with eosinophilic esophagitis
- •Presence of diabetes mellitus
- •Active H. Pylori infection or < 6 months after eradication
- •Predominant IBS (based on the Rome IV questionnaire)
- •Predominant GERD (based on the Rome IV questionnaire)
- •Patients taking prohibited medication
- •Females who are pregnant or lactating
- •Patients not capable to understand or be compliant with the study.
研究组 & 干预措施
Placebo + participant OFF-PPI
Patiënts that do not take PPI at baseline are randomized in the OFF-PPI PEA arm or OFF-PPI placebo arm
干预措施: Palmitoylethanolamide (Dietary Supplement)
Placebo + Participant ON-PPI
Patiënts that on baseline take daily PPI treatment are randomized in the ON-PPI PEA arm or ON-PPI placebo arm
干预措施: Palmitoylethanolamide (Dietary Supplement)
PEA + participant ON-PPI
Patiënts that on baseline take daily PPI treatment are randomized in the ON-PPI PEA arm or ON-PPI placebo arm
干预措施: Palmitoylethanolamide (Dietary Supplement)
PEA + participant OFF-PPI
Patiënts that do not take PPI at baseline are randomized in the OFF-PPI PEA arm or OFF-PPI placebo arm
干预措施: Palmitoylethanolamide (Dietary Supplement)
结局指标
主要结局
Effect (change) on the Leuven-postprandial distress scale (LPDS) (0-15), higher score indicating more symptoms)
时间窗: Comparison after 8 weeks of treatment with placebo or PEA
Validated questionnaire for measurement of dyspeptic symptoms in functional dyspepsia
次要结局
- Effect of PEA supplementation on duodenal permeability(Comparison after 8 weeks of treatment with placebo or PEA)
- Effect of PEA on gastric emptying(Comparison after 8 weeks of treatment with placebo or PEA)
- Effect of PEA supplementation on duodenal inflammation(Comparison after 8 weeks of treatment with placebo or PEA)