Abdominal DistentionNCT06285734
Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals With Abdominal Bloating/Distention
An observational study of Abdominal Distention and Abdominal Bloating, run by Shandong University at 1 site in China.
Trial summary
Abdominal bloating/distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Abdominal Distention, Abdominal Bloating
- What is being tested?
- Breath test
- How many people
- 387 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Jun 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Abdominal bloating/distension patients in the outpatient department.
Who may be able to join
- Patients aged 18 to 70 years.
- Patients presenting with the primary complaint of abdominal bloating and/or abdominal distension, or those exhibiting abdominal distension with prominence over other symptoms.
Who cannot join
- Patients who are pregnant or lactating.
- Patients have history of gastrointestinal malignancy or gastrointestinal surgery.
- Patients manifesting food intolerance or presenting with a confirmed diagnosis or suspicion of lactose intolerance.
- Patients with urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's disease, etc.), mental system (depression, etc.), or other diseases outside the digestive system.
- Patients who used antibiotics or microecological agents or underwent endoscopic examination within two weeks.
- Patients with a medication history encompassing motility enhancers, secretory enhancers, antifoaming agents, spasmolytics, opioids, and antidepressants within the past week.
- Patients who are unwilling or incapable to provide informed consents.
Trial locations and contacts
1 site in 1 country.
China1 site
Gastroenterology Department of Qilu Hospital
Jinan, Shandong, 250012
About this study
Abdominal bloating/distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO. In this study, the prevalence of SIBO irregularities in individuals presenting with abdominal bloating/distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal bloating/distention and SIBO was analysed to enhance the elucidation of the underlying etiology of abdominal bloating/distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal bloating/distention.
Read the detailed description
Abdominal bloating/distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. And the prevalence of Abdominal bloating/distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO. In this study, the prevalence of SIBO irregularities in individuals presenting with abdominal bloating/distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal bloating/distention and SIBO was analysed to enhance the elucidation of the underlying etiology of abdominal bloating/distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal bloating/distention.
- Conditions
- Abdominal Distention, Abdominal Bloating
- Being tested
- Breath test
- Keywords
- abdominal distention, small intestinal bacterial overgrowth, orocecal transit time, cross-sectional survey, abdominal bloating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath testDiagnostic test
The concentration of methane and hydrogen in the exhaled gas of patients with Abdominal bloating/distention is measured by a breath test to determine the presence of SIBO.
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive rate of SIBO in patients with abdominal bloating/distension
Detect the positive rate of SIBO in patients with abdominal bloating/distension by breath test
Measured: 2024-03-01 to 2026-06-01
Secondary outcomes (1)
Correlation between clinical features of patients with abdominal bloating/distension and SIBO
Analyze the correlation between clinical features of patients with abdominal bloating/distension and SIBO
Measured: 2024-03-01 to 2026-06-01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal DistentionStudies 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
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Jinan Central Hospital, Zaozhuang Municipal Hospital, Weifang People's Hospital, Dezhou Hospital Qilu Hospital of Shandong University, Binzhou Medical University, Qihe Xian Renmin Hospital
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
- Investigators
- Feixue Chen, MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285734
- Sponsor's protocol ID
- KYLL-202312-049
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals With Abdominal Bloating/Distention
- ClinicalTrials.gov ID
- NCT06285734
- Acronym / sponsor ID
- KYLL-202312-049
- Conditions
- Abdominal Distention, Abdominal Bloating
- Keywords
- abdominal distention, small intestinal bacterial overgrowth, orocecal transit time, cross-sectional survey, abdominal bloating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Jinan Central Hospital, Zaozhuang Municipal Hospital, Weifang People's Hospital, Dezhou Hospital Qilu Hospital of Shandong University, Binzhou Medical University, Qihe Xian Renmin Hospital
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 29 Feb 2024 (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.
Abdominal bloating/distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO. In this study, the prevalence of SIBO irregularities in individuals presenting with abdominal bloating/distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal bloating/distention and SIBO was analysed to enhance the elucidation of the underlying etiology of abdominal bloating/distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal bloating/distention.
Detailed description
Abdominal bloating/distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. And the prevalence of Abdominal bloating/distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO. In this study, the prevalence of SIBO irregularities in individuals presenting with abdominal bloating/distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal bloating/distention and SIBO was analysed to enhance the elucidation of the underlying etiology of abdominal bloating/distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal bloating/distention.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Abdominal bloating/distension patients in the outpatient department.
Key inclusion criteria (2 listed)
- Patients aged 18 to 70 years.
- Patients presenting with the primary complaint of abdominal bloating and/or abdominal distension, or those exhibiting abdominal distension with prominence over other symptoms.
Key exclusion criteria (7 listed)
- Patients who are pregnant or lactating.
- Patients have history of gastrointestinal malignancy or gastrointestinal surgery.
- Patients manifesting food intolerance or presenting with a confirmed diagnosis or suspicion of lactose intolerance.
- Patients with urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's disease, etc.), mental system (depression, etc.), or other diseases outside the digestive system.
- Patients who used antibiotics or microecological agents or underwent endoscopic examination within two weeks.
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 |
|---|---|---|
| Breath testThe concentration of methane and hydrogen in the exhaled gas of patients with Abdominal bloating/distention is measured by a breath test to determine the presence of SIBO. | Diagnostic test | – |
Primary outcome
Positive rate of SIBO in patients with abdominal bloating/distension
Time frame: 2024-03-01 to 2026-06-01
Detect the positive rate of SIBO in patients with abdominal bloating/distension by breath test
1 secondary outcome
Correlation between clinical features of patients with abdominal bloating/distension and SIBO
Time frame: 2024-03-01 to 2026-06-01
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 17 Sep 2026.
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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.
Feixue Chen, MD principal investigator
Qilu Hospital of Shandong 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 Abdominal Distention and Abdominal Bloating, run by Shandong 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 7 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 17 Sep 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?
Positive rate of SIBO in patients with abdominal bloating/distension (time frame: 2024-03-01 to 2026-06-01). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.