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NCT Number: NCT06285734

Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals with Abdominal Distention

Abdominal 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) and abnormal orocecal transit time (OCTT). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO and abnormalities in OCTT. In this study, the prevalence of SIBO and OCTT irregularities in individuals presenting with abdominal distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal distention and SIBO/OCTT was analysed to enhance the elucidation of the underlying etiology of abdominal distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal distention.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastroenterology Department of Qilu Hospital

Jinan, Shandong, 250012, China

Location status: Recruiting

Location contact

Professor Zuo

CONTACT

[email protected]

15662699906

About this study

Abdominal distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. And the prevalence of abdominal distension is high in the population. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO) and abnormal orocecal transit time (OCTT). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO and abnormalities in OCTT. In this study, the prevalence of SIBO and OCTT irregularities in individuals presenting with abdominal distention was ascertained through the implementation of the breath test. Furthermore, the correlation between the clinical features such as severity, location, and frequency of abdominal distension and SIBO/OCTT was analysed to enhance the elucidation of the underlying etiology of abdominal distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal 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 distention is measured by a breath test to determine the presence of SIBO and abnormal OCTT.

Primary outcomes

  1. Positive rate of SIBO in patients with abdominal distension

    Time frame: 2024-03-01 to 2025-08-01

    Detect the positive rate of SIBO in patients with abdominal distension by breath test

Secondary outcomes

  1. Positive rate of abnormal OCTT in patients with abdominal distension

    Time frame: 2024-03-01 to 2025-08-01

    Detect the positive rate of abnormal OCTT in patients with abdominal distension by breath test

  2. Correlation between clinical features of patients with abdominal distension and SIBO

    Time frame: 2024-03-01 to 2025-08-01

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

  3. Correlation between clinical features of patients with abdominal distension and OCTT

    Time frame: 2024-03-01 to 2025-08-01

    Analyze the correlation between clinical features of patients with abdominal distension and OCTT

Study contacts

Contact information is provided by the study sponsor or research team.

Xiuli Zuo, MD,PhD

CONTACT

[email protected]

15588818685

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

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

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 29, 2024
Registry last updated
Dec 12, 2024

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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