EUCTR2017-004355-23-BE进行中（未招募）1 期
Effect of Proton Pump Inhibitors on the duodenal microbiome in Functional Dyspepsia patients - PPI and duodenal microbiome in FD
TARGID, KU Leuven0 个研究点目标入组 20 人开始时间: 2017年12月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients with FD diagnosis as per Rome IV criteria
- •- Endoscopy needed as part of routine practice
- •- Subjects aged between 18 and 64 years inclusive
- •- Male or female (not pregnant or lactating and using
- •contraception or postmenopausal in FD cohort 1 only)
- •- Normal bowel habits (defecation once every 3 days up to 3 times a day)
- •- Witnessed written informed consent
- •- Access to home freezer (-18 to -20°C)
- •- Capable to understand and comply with the study requirements
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Any active somatic or psychiatric condition that can explain the dyspeptic symptoms (stable dose of single antidepressant allowed)
- •- Predominant symptoms of gastro-esophageal reflux disease (GERD) or irritable bowel syndrome (IBS)
- •- Use of immunosuppressants or antibiotics within 3 months before sampling
- •- Use of drugs influencing gut motility or stool consistency, NSAIDs, anti-allergy drugs, bile acid sequestrants or ursodeoxycholic acid within 2 weeks before sampling
- •- History of major abdominal surgery, including cholecystectomy but not appendectomy
- •-Personal or family (first-degree relative) history of diabetes mellitus type 1, celiac disease, inflammatory bowel disease, psoriasis, rheumatic or other auto-immune diseases (including therapy)
- •-Allergy or atopy (eczema, asthma and/or allergic rhinoconjunctivitis) (including therapy)
- •-Kidney, liver or coagulation disorders
- •-Active coronary or peripheral artery disease
- •-Diabetes mellitus type 2 (including therapy)
- •- Active malignancy (including therapy)
- •-Known HIV, HBV or HCV infection (including therapy)
- •- Magnetizable objects (e.g. cochlear implants, neural stimulator, pacemaker, metal fragments or implants) or claustrophobia (MRI safety criteria, other procedures can still take place)
- •- Significant alcohol use (>10 units/weeks)
- •- Any use of alcohol or smoking in the 2 days before sampling
- •- Females who are pregnant or lactating, who are not using contraception and premenopausal (FD cohort 1 only)
- •- Allergy or intolerance to PPI (FD cohort 1 only)
研究者
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