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Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals With Abdominal Bloating/Distention

Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals With Abdominal Bloating/Distention

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06285734
Enrollment
387
Registered
2024-02-29
Start date
2024-03-01
Completion date
2026-06-01
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Bloating, Abdominal Distention

Keywords

abdominal distention, small intestinal bacterial overgrowth, orocecal transit time, cross-sectional survey, abdominal bloating

Brief 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). 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.

Interventions

DIAGNOSTIC_TESTBreath 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.

Sponsors

Shandong University
Lead SponsorOTHER
Jinan Central Hospital
CollaboratorOTHER
Zaozhuang Municipal Hospital
CollaboratorOTHER
Weifang People's Hospital
CollaboratorOTHER
Dezhou Hospital Qilu Hospital of Shandong University
CollaboratorOTHER
Binzhou Medical University
CollaboratorOTHER
Qihe Xian Renmin Hospital
CollaboratorUNKNOWN

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Patients aged 18 to 70 years. 2. Patients presenting with the primary complaint of abdominal bloating and/or abdominal distension, or those exhibiting abdominal distension with prominence over other symptoms.

Exclusion criteria

1. Patients who are pregnant or lactating. 2. Patients have history of gastrointestinal malignancy or gastrointestinal surgery. 3. Patients manifesting food intolerance or presenting with a confirmed diagnosis or suspicion of lactose intolerance. 4. 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. 5. Patients who used antibiotics or microecological agents or underwent endoscopic examination within two weeks. 6. Patients with a medication history encompassing motility enhancers, secretory enhancers, antifoaming agents, spasmolytics, opioids, and antidepressants within the past week. 7. Patients who are unwilling or incapable to provide informed consents.

Design outcomes

Primary

MeasureTime frameDescription
Positive rate of SIBO in patients with abdominal bloating/distension2024-03-01 to 2026-06-01Detect the positive rate of SIBO in patients with abdominal bloating/distension by breath test

Secondary

MeasureTime frameDescription
Correlation between clinical features of patients with abdominal bloating/distension and SIBO2024-03-01 to 2026-06-01Analyze the correlation between clinical features of patients with abdominal bloating/distension and SIBO

Countries

China

Contacts

PRINCIPAL_INVESTIGATORFeixue Chen, MD

Qilu Hospital of Shandong University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026