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

Abdominal Distention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06285734
• Other study ID #: KYLL-202312-049
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: January 7, 2025

Study information

• Verified date: February 2024
• Source: Shandong University
• Contact: Xiuli Zuo, MD,PhD
• Phone: 15588818685
• Email: zuoxiuli[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 402
• Est. completion date: January 7, 2025
• Est. primary completion date: January 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Distention

Intervention

Diagnostic Test:
• Breath 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.

Locations

Country	Name	City	State
n/a

Sponsors (10)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 2025-01-07
Secondary	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 2025-01-07
Secondary	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 2025-01-07
Secondary	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 2025-01-07