Clinical trial NCT06285734: Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals with Abdominal Distention
Official title: Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals with Abdominal Distention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Distention
Keywords: abdominal distention
small intestinal bacterial overgrowth
orocecal transit time
cross-sectional survey
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University (Qingdao)
name: Jinan Central Hospital
name: Zaozhuang Municipal Hospital
name: Weihai Municipal Hospital
name: Central Hospital of Zibo
name: Weifang People's Hospital
name: Qilu hospital of Shandong University Dezhou hospital
name: Binzhou Medical University
name: Qihe Xian Renmin Hospital
First posted: 2024-02-29
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Abdominal distension patients in the outpatient department at Qilu Hospital of Shandong University.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Positive rate of SIBO in patients with abdominal distension
timeFrame: 2024-03-01 to 2025-08-01
Secondary outcomes:
measure: Positive rate of abnormal OCTT in patients with abdominal distension
timeFrame: 2024-03-01 to 2025-08-01
measure: Correlation between clinical features of patients with abdominal distension and SIBO
timeFrame: 2024-03-01 to 2025-08-01
measure: Correlation between clinical features of patients with abdominal distension and OCTT
timeFrame: 2024-03-01 to 2025-08-01
Other outcomes:
Locations:
city: Jinan
country: China
facility: Gastroenterology Department of Qilu Hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Feixue Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: