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

Last updated: December 7, 2024
Sponsor: Shandong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Breath test

Clinical Study ID

NCT06285734
KYLL-202312-049
  • Ages 18-60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged 18 to 70 years.

  2. Patients presenting with the primary complaint of abdominal bloating and/orabdominal distension, or those exhibiting abdominal distension with prominence overother symptoms.

Exclusion

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 orsuspicion 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 endoscopicexamination within two weeks.

  6. Patients with a medication history encompassing motility enhancers, secretoryenhancers, antifoaming agents, spasmolytics, opioids, and antidepressants within thepast week.

  7. Patients who are unwilling or incapable to provide informed consents.

Study Design

Total Participants: 402
Treatment Group(s): 1
Primary Treatment: Breath test
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
August 01, 2025

Study Description

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.

Connect with a study center

  • Gastroenterology Department of Qilu Hospital

    Jinan, Shandong 250012
    China

    Active - Recruiting

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