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

NCT06285734 | Recruiting

• 1 other identifier: KYLL-202312-049
• Study Type: observational
• Target: 402
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Distention

Keywords

abdominal distention; small intestinal bacterial overgrowth; orocecal transit time; cross-sectional survey

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Positive rate of abnormal OCTT in patients with abdominal distension

  2024-03-01 to 2025-08-01

• 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

  2024-03-01 to 2025-08-01

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Gastroenterology Department of Qilu Hospital

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The exhaled air of the patient after taking the substrate.

MeSH Terms

Interventions

Breath Tests

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Feixue Chen, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, MD,PhD

CONTACT

15588818685; zuoxiuli@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of gastroenterology department of Qilu hospital

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 29, 2024
• Study Start: March 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)