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

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 Overview

• Status: Completed
• Conditions: Abdominal Distention; Abdominal Bloating
• Intervention / Treatment: Diagnostic test: Breath test

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 Type: Observational
• Enrollment (Actual): 387

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Gastroenterology Department of Qilu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Abdominal bloating/distension patients in the outpatient department.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2024-03-01 to 2026-06-01

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2024-03-01 to 2026-06-01

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: Jinan Central Hospital; Weifang People's Hospital; Binzhou Medical University; Zaozhuang Municipal Hospital; Qihe Xian Renmin Hospital; Dezhou Hospital Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Feixue Chen, MD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): June 1, 2026
• Study Completion (Actual): June 1, 2026

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: abdominal bloating; abdominal distention; small intestinal bacterial overgrowth; cross-sectional survey; orocecal transit time
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic; Diagnostic Techniques and Procedures; Diagnosis; Breath Tests
• Other Study ID Numbers: KYLL-202312-049

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No