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

NCT07122284 | Completed

• 1 other identifier: ZYC-SIBO2025
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (2)

• 13C-Urea Breath Test

  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.

  day 0, Patient baseline levels at enrollment

• Hydrogen-Methane Breath Test

  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.

  day 0, Patient baseline levels at enrollment

Study Arms (4)

Group A

H. pylori-positive and SIBO-positive group

Diagnostic Test: 13C-Urea Breath Test; Diagnostic Test: Hydrogen-Methane Breath Test

Group B

H. pylori-negative and SIBO-positive group

Diagnostic Test: 13C-Urea Breath Test; Diagnostic Test: Hydrogen-Methane Breath Test

Group C

H. pylori-positive and SIBO-negative group

Diagnostic Test: 13C-Urea Breath Test; Diagnostic Test: Hydrogen-Methane Breath Test

Group D

H. pylori-negative and SIBO-negative group

Diagnostic Test: 13C-Urea Breath Test; Diagnostic Test: Hydrogen-Methane Breath Test

Interventions

13C-Urea Breath Test DIAGNOSTIC_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.

Group A; Group B; Group C; Group D

Hydrogen-Methane Breath Test DIAGNOSTIC_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.

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A prospective observational cohort of adult patients (aged 18-65 years) with concomitant Helicobacter pylori infection and small intestinal bacterial overgrowth (SIBO) was enrolled at Zhongshan Hospital (Xiamen), Fudan University.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Hospital (Xiamen), Fudan University: lead

Study Sites (1)

Zhongshan Hospital (Xiamen), Fudan University

Xiamen, Fujian, 361015, China

Location

Related Publications (2)

• Wang X, Zhu D, Li S, Dai Y, Teng G, Wang W. Influence of Helicobacter pylori Infection and Eradication on Small Intestinal Bacterial Overgrowth and Abdominal Symptoms. Dig Dis Sci. 2024 Apr;69(4):1293-1301. doi: 10.1007/s10620-024-08279-y. Epub 2024 Feb 15.

  PMID: 38363519 RESULT

• Nelson JM, Rizzo JM, Greene RK, Fahlstrom K, Troost JP, Helfrich YR, Nakamura M. Evaluation of Helicobacter pylori and Small Intestinal Bacterial Overgrowth in Subjects With Rosacea. Cureus. 2024 Oct 25;16(10):e72363. doi: 10.7759/cureus.72363. eCollection 2024 Oct.

  PMID: 39583431 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Metagenomics and metabolomics.

Study Officials

• Wei Jiang, M.D.

  Zhongshan Hospital (Xiamen), Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 14, 2025
• Study Start: January 31, 2024
• Primary Completion: December 30, 2024
• Study Completion: February 28, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)