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

NCT07122284 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

  • Gut Microbiota
  • Metabolic Profiles
  • Helicobacter Pylori Infection
  • Small Intestinal Bacterial Overgrowth

Interventions

DIAGNOSTIC_TEST

13C-Urea Breath Test

Participants underwent the 13C-urea breath test following a standardized protocol to detect active Helicobacter pylori (H. pylori) infection. After an overnight fast (≥8 hours), baseline breath samples were collected by exhaling gently through a straw. Participants then ingested 75 mg of 13C-labeled urea dissolved in 50 mL of citric acid solution to delay gastric emptying and maximize urease exposure. A second breath sample was collected 30 minutes post-ingestion using identical procedures.

DIAGNOSTIC_TEST

Hydrogen-Methane Breath Test

Participants underwent a standardized hydrogen-methane breath test to evaluate for small intestinal bacterial overgrowth (SIBO) or carbohydrate malabsorption. After a 12-hour overnight fast, baseline breath samples were collected via controlled end-expiratory exhalation. Participants then ingested a substrate solution.

Sponsors & Collaborators

  • Zhongshan Hospital (Xiamen), Fudan University

    lead OTHER

Principal Investigators

  • Wei Jiang, M.D. · Zhongshan Hospital (Xiamen), Fudan University

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2024-12-30
Completion
2025-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07122284 on ClinicalTrials.gov