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OpenTrials
Completed

NCT Number: NCT06285734

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastroenterology Department of Qilu Hospital

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 2024-03-01 to 2026-06-01

    Analyze the correlation between clinical features of patients with abdominal bloating/distension and SIBO

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

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

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 29, 2024
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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