2024-517679-18-00招募中4 期
Effect of proton pump inhibitors on the structural integrity of endoscopic sleeve gastroplasty: a single-centre open-label, randomized, controlled pilot clinical trial
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the assess the effect of PPIs on the proportion of patients with “Intact ESG”, “open ESG” and “partially intact ESG” at 6 months of follow-up
研究概览
简要总结
To evaluate the effect of PPI’s on the structural integrity of the ESG
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 65 years
- •BMI between 30 to 45 kg/m2
- •Willingness to participate in the study and ability to comply and understand the study protocol
排除标准
- •Active gastric gastro-duodenal during the last 6 months
- •Continuous glucocorticoid or anti-inflammatory treatment
- •Uncontrolled thyroid disease
- •Pregnancy, breastfeeding
- •Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study
- •Hiatal hernia ≥ 5 cm
- •Known allergy or hypersensitivity to the active substance or any of the other excipients
- •Liver cirrhosis of any Child-Phugh stage or MELD> 15
- •Chronic Severe Renal Insufficiency (eGFR < 30 ml/min/1.73 m2 based on CKD-EPI equation)
- •Currently participating in other study, or previously participated in an experimental drugs trial within 30 days before or 5 half-life of the drug administered
- •Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.
- •Helicobacter pylori infection
- •Organic or motility disorder of the stomach and / or esophagus
- •Anticoagulant treatment
- •Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum
- •Ongoing or active malignancy during the last 5 years
- •Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association’s classification
- •Drug or alcohol abuse
- •Bulimic or binge eating pattern
结局指标
主要结局
the assess the effect of PPIs on the proportion of patients with “Intact ESG”, “open ESG” and “partially intact ESG” at 6 months of follow-up
the assess the effect of PPIs on the proportion of patients with “Intact ESG”, “open ESG” and “partially intact ESG” at 6 months of follow-up
次要结局
- to assess the effect of PPI on the proportion of patients with “intact ESG”, “partially intact ESG” and “open ESG”, separately, at 12 months of follow-up.
研究者
Ivo Boskoski
Scientific
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究点 (1)
Loading locations...
相似试验
招募中
不适用
The effect of proton pump inhibitor on quality of life after gastrointestinal surgeryJPRN-UMIN000005326Department of Surgery, The Jikei University School of Medicine690
尚未招募
不适用
A study on the effect of proton pump inhibitors on the intragastric pH for the patients of functional dysplasiaFunctional dyspepsia(FD)JPRN-UMIN000003127FD-pH Society60
未知
不适用
Research on the effect of a proton pump inhibitor on the oral and intestinal microbiota and salivary protein and metabolites.healthy volunteerJPRN-UMIN000025331Shimane university24
已完成
不适用
The effect of proton pump inhibitor and potassium competitive acid blocker toward endothelial cells.healthy adultsJPRN-UMIN000024875Hamamatsu University School of Medicine70
进行中（未招募）
1 期
PPI in walnut allergyEUCTR2015-001863-38-ESFundación para la investigación biomedica del hospital clinico san carlos de madrid60