Gut MicrobiotaNCT07122284
Gut Microbiome-Metabolome Profiling in H. Pylori-SIBO Comorbidity
An observational study of Gut Microbiota and Metabolic Profiles, run by Zhongshan Hospital (Xiamen), Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gut Microbiota, Metabolic Profiles, Helicobacter Pylori Infection
- What is being tested?
- 13C-Urea Breath Test and Hydrogen-Methane Breath Test
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age from 18 to 65 years;
- All enrolled patients underwent both the 13C-urea breath test (13C-UBT) and hydrogen-methane breath test (HMBT).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital (Xiamen), Fudan University
Xiamen, Fujian, 361015
About this study
Official title: Characterization of Gut Microbiota and Metabolic Profiles in Patients With Helicobacter Pylori Infection and Small Intestinal Bacterial Overgrowth Based on Metagenomic and Metabolomic Analyses
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.
Read the detailed description
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.
- Conditions
- Gut Microbiota, Metabolic Profiles, Helicobacter Pylori Infection, Small Intestinal Bacterial Overgrowth
- Being tested
- 13C-Urea Breath Test, Hydrogen-Methane Breath Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C-Urea Breath TestDiagnostic 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.
Hydrogen-Methane Breath TestDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | H. pylori-positive and SIBO-positive group Receives: Diagnostic Test: 13C-Urea Breath Test; Diagnostic Test: Hydrogen-Methane Breath Test | |
| Group B | H. pylori-negative and SIBO-positive group Receives: Diagnostic Test: 13C-Urea Breath Test; Diagnostic Test: Hydrogen-Methane Breath Test | |
| Group C | H. pylori-positive and SIBO-negative group Receives: Diagnostic Test: 13C-Urea Breath Test; Diagnostic Test: Hydrogen-Methane Breath Test | |
| Group D | H. pylori-negative and SIBO-negative group Receives: Diagnostic Test: 13C-Urea Breath Test; Diagnostic Test: Hydrogen-Methane Breath Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: day 0, Patient baseline levels at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start31 Jan 2024
- Primary completion30 Dec 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongshan Hospital (Xiamen), Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yucheng Zhu, Zhongshan Hospital (Xiamen), Fudan University
- Investigators
- Wei Jiang, M.D., Study director, Zhongshan Hospital (Xiamen), Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122284
- Sponsor's protocol ID
- ZYC-SIBO2025
- Status last verified
- Mar 2026
- First submitted
- 6 Aug 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38363519Nelson 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.
PubMed 39583431
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Gut Microbiota and Metabolic Profiles in Patients With Helicobacter Pylori Infection and Small Intestinal Bacterial Overgrowth Based on Metagenomic and Metabolomic Analyses
- ClinicalTrials.gov ID
- NCT07122284
- Acronym / sponsor ID
- ZYC-SIBO2025
- Conditions
- Gut Microbiota, Metabolic Profiles, Helicobacter Pylori Infection, Small Intestinal Bacterial Overgrowth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Zhongshan Hospital (Xiamen), Fudan UniversityUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: 13C-Urea Breath Test, Diagnostic Test: Hydrogen-Methane Breath TestH. pylori-positive and SIBO-positive group |
| Group B | – | Diagnostic Test: 13C-Urea Breath Test, Diagnostic Test: Hydrogen-Methane Breath TestH. pylori-negative and SIBO-positive group |
| Group C | – | Diagnostic Test: 13C-Urea Breath Test, Diagnostic Test: Hydrogen-Methane Breath TestH. pylori-positive and SIBO-negative group |
| Group D | – | Diagnostic Test: 13C-Urea Breath Test, Diagnostic Test: Hydrogen-Methane Breath TestH. pylori-negative and SIBO-negative group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age from 18 to 65 years;
- All enrolled patients underwent both the 13C-urea breath test (13C-UBT) and hydrogen-methane breath test (HMBT).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13C-Urea Breath TestParticipants 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 | Group A, Group B, Group C, Group D |
| Hydrogen-Methane Breath TestParticipants 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. | Diagnostic test | Group A, Group B, Group C, Group D |
Primary outcome
13C-Urea Breath Test
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Results publication: PubMed 38363519Wang 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.
- Results publication: PubMed 39583431Nelson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Jiang, M.D. study director
Zhongshan Hospital (Xiamen), Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Microbiota and Metabolic Profiles, run by Zhongshan Hospital (Xiamen), Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
13C-Urea Breath Test (time frame: day 0, Patient baseline levels at enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07122284, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.