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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Distention
• Intervention / Treatment: Diagnostic test: Breath test

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 402

Contacts and Locations

• Study Contact: Name: Xiuli Zuo, MD,PhD; Phone Number: 15588818685; Email: zuoxiuli@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Gastroenterology Department of Qilu Hospital
      • Contact: Professor Zuo; Phone Number: 15662699906; Email: lcyxwxq@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Abdominal distension patients in the outpatient department at Qilu Hospital of Shandong University.

Description

Inclusion Criteria:

1. Patients aged 18 to 70 years.
2. 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:

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 or suspicion 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 endoscopic examination within two weeks.
6. Patients with a medication history encompassing motility enhancers, secretory enhancers, antifoaming agents, spasmolytics, opioids, and antidepressants within the past week.
7. Patients who are unwilling or incapable to provide informed consents.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive rate of SIBO in patients with abdominal distension	Detect the positive rate of SIBO in patients with abdominal distension by breath test	2024-03-01 to 2025-08-01

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive rate of abnormal OCTT in patients with abdominal distension	Detect the positive rate of abnormal OCTT in patients with abdominal distension by breath test	2024-03-01 to 2025-08-01
Correlation between clinical features of patients with abdominal distension and SIBO	Analyze the correlation between clinical features of patients with abdominal distension and SIBO	2024-03-01 to 2025-08-01
Correlation between clinical features of patients with abdominal distension and OCTT	Analyze the correlation between clinical features of patients with abdominal distension and OCTT	2024-03-01 to 2025-08-01

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: Jinan Central Hospital; Weihai Municipal Hospital; Weifang People's Hospital; Qilu Hospital of Shandong University (Qingdao); Binzhou Medical University; Zaozhuang Municipal Hospital; Central Hospital of Zibo; Qilu hospital of Shandong University Dezhou hospital; Qihe Xian Renmin Hospital
• Investigators: Principal Investigator: Feixue Chen, MD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 7, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: abdominal distention; small intestinal bacterial overgrowth; cross-sectional survey; orocecal transit time
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: KYLL-202312-049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No