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

StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Primary endpoint(s) modified Show 9 more changesShow less
    • Primary completion date changed from estimate of Aug 1, 2025 to Jun 1, 2026
    • Trial completed
    • Enrollment target: estimated 402 to confirmed 387
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 3 to 1
    • Study description shortened, about 15 words
    • Site details revised
    • Collaborators: 9 to 6
    • Study title revised
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary and study completion dates: Jan 7, 2025 to Aug 1, 2025
    • Study sites: 0 to 1
    • Secondary endpoints: details revised at 3 of 3 entries
    • Collaborators reordered
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06285734
Lead Sponsor Shandong University
Collaborators: Jinan Central Hospital, Zaozhuang Municipal Hospital, Weifang People's Hospital, Dezhou Hospital Qilu Hospital of Shandong University, Binzhou Medical University, Qihe Xian Renmin Hospital
Conditions
(from sponsor)		 Abdominal Distention, Abdominal Bloating
Enrollment 387 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov