Clinical Trial

Gut Microbiome-Metabolome Profiling in H. Pylori-SIBO Comorbidity

Completed
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-12.
Trial Details
NCT Number NCT07122284
Lead Sponsor Zhongshan Hospital (Xiamen), Fudan University
Conditions Gut Microbiota, Metabolic Profiles, Helicobacter Pylori Infection, Small Intestinal Bacterial Overgrowth
Enrollment 42 participants
Start Date 2024-01-31
Primary Completion 2024-12-30 (estimated)
Study Completion 2025-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-03-25