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临床试验/NCT06268834
NCT06268834已完成不适用

Is Long-Term Proton Pump Inhibitor Use a Cause of Leaky Gut Syndrome: A Cross-Sectional Case-Control Study

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 75 人开始时间: 2023年10月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
2
主要终点
Zonulin levels in long-term proton pump inhibitor users

研究概览

简要总结

Our study aims to investigate the effect of bacterial overgrowth induced by long-term PPI use on zonulin levels.

详细描述

The study included a total of 75 participants, with 45 individuals classified as long-term PPI users and 30 as non-PPI users. The PPI user group was defined as those who had been consistently using PPIs (specifically omeprazole, lansoprazole, pantoprazole, esomeprazole, or rabeprazole) on a daily basis for a minimum of 6 months or at least twice a week for a minimum of 2 years. The control group comprised individuals who had never used PPIs. Venous blood samples were taken from all participants to measure serum zonulin levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient group was patients taking long-term PPIs (omeprazole, lansoprazole, pantoprazole, esomeprazole and rabeprazole) every day for at least 6 months or at least twice a week for at least 2 years.
  • A control group was formed from individuals who had never used PPI.

排除标准

  • Those with inflammatory bowel disease, celiac disease, type 1 diabetes, active gastroenteritis, acute kidney failure, chronic kidney failure, and those who had used antibiotics for any reason in the last 3 months, as well as those receiving probiotic drug support, were not included in the study

研究组 & 干预措施

Using PPI

Experimental

Group receiving a long-term PPI (omeprazole, lansoprazole, pantoprazole, esomeprazole and rabeprazole) every day for at least 6 months or at least twice a week for at least 2 years.

干预措施: Blood for zonulin level was drawn from the group. (Diagnostic Test)

Control

Experimental

A control group was formed from individuals who had never used PPI.

干预措施: Blood for zonulin level was drawn from the group. (Diagnostic Test)

结局指标

主要结局

Zonulin levels in long-term proton pump inhibitor users

时间窗: Blood was drawn and collected during the examination and studied collectively after 3 months

Approximately 5 cc of blood was drawn from the antebrachial veins of the patients to determine serum zonulin levels. Serum örnekleri -80 santigrat derecede 3 ay süreyle saklanmıştır. Serum örneklerindeki Zonulin seviyeleri Shanghai Crystal Day Biotech Co, Ltd, Shanghai, Çin'den ticari BT-LAB Human Zonulin ELISA kitleri (Kat. No. E1117Hu) kullanılarak ölçülmüştür. The test range of the kit was 2-600 ng/ml. The sensitivity of the test was 1.09 ng/ml. A serum zonulin level above 12 ng/ml was considered positive.

次要结局

未报告次要终点

研究者

发起方
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Semih Sezer

clinic physician

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

研究点 (2)

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