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

NCT06285734 | Completed

• 1 other identifier: KYLL-202312-049
• Study Type: observational
• Target: 387
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Distention; Abdominal Bloating

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between clinical features of patients with abdominal bloating/distension and SIBO

  2024-03-01 to 2026-06-01

Interventions

Breath test DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Abdominal bloating/distension patients in the outpatient department.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead
• Jinan Central Hospital: collaborator
• Zaozhuang Municipal Hospital: collaborator
• Binzhou Medical University: collaborator
• Qihe Xian Renmin Hospital: collaborator
• Dezhou Hospital Qilu Hospital of Shandong University: collaborator
• Weifang People's Hospital: collaborator

Study Sites (1)

Gastroenterology Department of Qilu Hospital

Jinan, Shandong, 250012, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The exhaled air of the patient after taking the substrate.

MeSH Terms

Interventions

Breath Tests

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Feixue Chen, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of gastroenterology department of Qilu hospital

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 29, 2024
• Study Start: March 1, 2024
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-09

Locations

CN (1)