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临床试验/NCT07122284
NCT07122284已完成不适用

Characterization of Gut Microbiota and Metabolic Profiles in Patients With Helicobacter Pylori Infection and Small Intestinal Bacterial Overgrowth Based on Metagenomic and Metabolomic Analyses

Zhongshan Hospital (Xiamen), Fudan University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
13C-Urea Breath Test

研究概览

简要总结

Patients with concurrent Helicobacter pylori infection and small intestinal bacterial overgrowth (SIBO) represent a clinically challenging subgroup, often experiencing refractory gastrointestinal symptoms and diminished treatment responses. Current evidence indicates that individuals infected with H. pylori may related SIBO as a comorbidity; however, the synergistic effects of these conditions on gut ecosystem homeostasis remain poorly understood. To address this knowledge gap, we employed a dual-omics approach that combined shotgun metagenomic sequencing with liquid chromatography-mass spectrometry (LC-MS) metabolomic profiling. This methodology allowed for a comprehensive mapping of microbial community structures, including species-level taxonomy and functional pathways, as well as host-microbiota co-metabolism signatures in fecal samples.

详细描述

Patients presenting with concurrent Helicobacter pylori infection and small intestinal bacterial overgrowth (SIBO) constitute a clinically challenging subgroup characterized by refractory gastrointestinal symptoms and diminished responses to standard therapeutic interventions. Current evidence supports an association between H. pylori infection and an increased prevalence of SIBO as a comorbidity. However, the synergistic effects of these two conditions on the fundamental mechanisms governing gut ecosystem homeostasis - particularly concerning microbial community dynamics, functional metabolic output, and host-microbial interactions - remain poorly understood, representing a significant knowledge gap.

To systematically address this gap and elucidate the complex interplay, we implemented an integrated dual-omics analytical approach. This methodology combined shotgun metagenomic sequencing of fecal samples with liquid chromatography-mass spectrometry (LC-MS) metabolomic profiling. This powerful combination enables a comprehensive mapping of the gut ecosystem by simultaneously characterizing: Host-Microbiota Co-Metabolism Signatures: Revealing the metabolic landscape through the detection and quantification of metabolites derived from microbial activity, host metabolism, and crucially, their interactions (co-metabolism) within the fecal metabolome.

This multimodal strategy offers an unprecedented, holistic view of the perturbations induced by the co-occurrence of H. pylori infection and SIBO, moving beyond singular aspects to capture the integrated functional and compositional state of the gut ecosystem.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 18 to 65 years;
  • All enrolled patients underwent both the 13C-urea breath test (13C-UBT) and hydrogen-methane breath test (HMBT).

排除标准

  • Coexistence of significant concomitant illnesses, including heart disease, renal failure, hepatic disease, previous abdominal surgery, lactation, or pregnancy;
  • Patients who had used probiotics and antibiotics in the past 12 weeks;
  • Unwillingness to participate in this study.

结局指标

主要结局

13C-Urea Breath Test

时间窗: day 0, Patient baseline levels at enrollment

The 13C-Urea Breath Test (13C-UBT) is a non-invasive, highly specific diagnostic assay used to detect active Helicobacter pylori (H. pylori) infection in the gastric mucosa. It leverages the bacterium's unique enzymatic activity-urease production-to metabolize ingested labeled urea, resulting in measurable changes in exhaled breath CO₂ isotopic composition.

Hydrogen-Methane Breath Test

时间窗: day 0, Patient baseline levels at enrollment

The Hydrogen-Methane Breath Test (HMBT) is a non-invasive, gold-standard diagnostic tool for detecting small intestinal bacterial overgrowth (SIBO) and carbohydrate malabsorption disorders . It quantifies microbial fermentation activity in the gut by measuring gaseous metabolic end-products (H₂ and CH₄) in exhaled breath following substrate administration.

次要结局

未报告次要终点

研究者

发起方
Zhongshan Hospital (Xiamen), Fudan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yucheng Zhu

Deputy Chief Physician

Zhongshan Hospital (Xiamen), Fudan University

研究点 (1)

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