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Effect of Omeprazole on Gut Microbiota in Adults With Obesity and GERD

2026年9月24日 更新者：Federal State Budgetary Scientific Institution

Effect of Proton Pump Inhibitors on Gut Microbiota Composition in Adults With Obesity and Gastroesophageal Reflux Disease

This randomized, open-label, parallel-group study will evaluate the effect of short-term omeprazole therapy on gut and oral microbiota in adults aged 50-65 years with obesity and symptomatic gastroesophageal reflux disease. Participants will be randomized 1:1 to receive omeprazole 20 mg once daily for 14 days plus standard non-pharmacological recommendations for gastroesophageal reflux disease, or standard non-pharmacological recommendations alone. Clinical and laboratory assessments will be performed at baseline and after 14 days. Stool and saliva samples will be collected to assess gut and oral microbiota, and blood samples will be collected for laboratory biomarkers.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

26

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Georgy E. Leonov, MD, PhD
  • 电话号码：+7 9055687783
  • 邮箱：golerus@gmail.com

学习地点

  • 俄罗斯
      • Moscow、俄罗斯、115446
        • Federal Research Centre of Nutrition, Biotechnology and Food Safety
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 50 to 65 years, inclusive.
  • Obesity, defined as body mass index (BMI) ≥30 kg/m².
  • Symptomatic gastroesophageal reflux disease with mild or moderate typical symptoms, including heartburn and/or regurgitation.
  • For female participants, postmenopausal status, defined as absence of menstruation for at least 12 months without another apparent cause of amenorrhea.
  • Written informed consent to participate in the study.

Exclusion Criteria:

  • Severe or exacerbated GERD, or GERD requiring acid-suppressive therapy or additional diagnostic evaluation.
  • Use of proton pump inhibitors or histamine H2-receptor antagonists within 8 weeks prior to enrollment.
  • Use of systemic antibiotics within 3 months prior to enrollment.
  • Use of probiotic or synbiotic supplements within 8 weeks prior to enrollment.
  • Inflammatory bowel disease, celiac disease, or other severe chronic gastrointestinal disorders that may substantially affect the gut microbiota.
  • History of bariatric surgery or other major gastrointestinal surgery.
  • Acute infectious or inflammatory disease at enrollment.
  • History of myocardial infarction or stroke.
  • Type 2 diabetes mellitus.
  • Chronic heart failure, New York Heart Association functional class III-IV.
  • Chronic kidney disease with estimated glomerular filtration rate <30 mL/min/1.73 m².
  • Alcohol dependence or other substance use disorder.
  • Severe psychiatric disorder or cognitive impairment that may interfere with providing informed consent or adherence to the study protocol.
  • Known hypersensitivity or contraindications to omeprazole.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Omeprazole Plus Standard Non-pharmacological Recommendations

Participants will receive omeprazole 20 mg orally once daily for 14 days in addition to standard non-pharmacological recommendations for gastroesophageal reflux disease.
药品：Omeprazole

Omeprazole 20 mg administered orally once daily for 14 days.

行为的：Standard Non-pharmacological Recommendations for GERD

Standard non-pharmacological recommendations for gastroesophageal reflux disease management.
有源比较器：Standard Non-pharmacological Recommendations

Participants will receive standard non-pharmacological recommendations for gastroesophageal reflux disease for 14 days.
行为的：Standard Non-pharmacological Recommendations for GERD

Standard non-pharmacological recommendations for gastroesophageal reflux disease management.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in gut microbiota beta diversity
大体时间：Baseline and Day 14

Gut microbiota beta diversity will be assessed using distance-based measures derived from 16S rRNA gene sequencing of stool samples, including Bray-Curtis dissimilarity and phylogenetic UniFrac distances.
Baseline and Day 14

次要结果测量

结果测量
措施说明
大体时间
Change in Shannon diversity index
大体时间：Baseline and Day 14

Change in gut microbiota alpha diversity assessed using the Shannon diversity index derived from 16S rRNA gene sequencing of stool samples. Higher values indicate greater microbial diversity.
Baseline and Day 14
Change in Simpson diversity index
大体时间：Baseline and Day 14

Change in gut microbiota alpha diversity assessed using the Simpson diversity index derived from 16S rRNA gene sequencing of stool samples. Values range from 0 to 1, with higher values indicating greater microbial diversity.
Baseline and Day 14
Change in Chao1 richness estimator
大体时间：Baseline and Day 14

Change in gut microbiota richness assessed using the Chao1 richness estimator derived from 16S rRNA gene sequencing of stool samples. Higher values indicate greater estimated microbial richness.
Baseline and Day 14
Change in modified Frequency Scale for the Symptoms of GERD total score
大体时间：Baseline and Day 14

Change in the total modified Frequency Scale for the Symptoms of GERD (mFSSG) score from baseline to Day 14. The questionnaire includes 14 items scored from 0 to 4. The total score ranges from 0 to 56, with higher scores indicating more frequent GERD-related symptoms.
Baseline and Day 14
Change in high-sensitivity C-reactive protein concentration
大体时间：Baseline and Day 14

Change in serum high-sensitivity C-reactive protein (hs-CRP) concentration.
Baseline and Day 14
Change in systemic immune-inflammation index
大体时间：Baseline and Day 14

Change in the systemic immune-inflammation index (SII), calculated as platelet count × neutrophil count / lymphocyte count.
Baseline and Day 14

其他结果措施

结果测量
措施说明
大体时间
Change in oral microbiota composition
大体时间：Baseline and Day 14

Changes in oral microbiota composition will be assessed using microbiome analysis of saliva samples, including measures of microbial diversity and taxonomic composition.
Baseline and Day 14
Change in serum lipopolysaccharide-binding protein concentration
大体时间：Baseline and Day 14

Change in serum lipopolysaccharide-binding protein (LBP) concentration from baseline to Day 14.
Baseline and Day 14

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Federal State Budgetary Scientific Institution

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月25日

初级完成 (估计的)

2026年12月25日

研究完成 (估计的)

2026年12月25日

研究注册日期

首次提交

2026年9月24日

首先提交符合 QC 标准的

2026年9月24日

首次发布 (实际的)

2026年10月1日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PPI-MICROBIOME-7-02-09-2026
  • 22-15-00252-P (其他赠款/资助编号：Russian Science Foundation)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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