Understanding small intestinal bacterial overgrowth in patients with abdominal distention
Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals with Abdominal Distention
This study looks at whether people with bloating have small intestinal bacterial overgrowth and how it relates to their symptoms, using a simple breath test.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 402 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06285734 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the prevalence of small intestinal bacterial overgrowth (SIBO) and abnormal orocecal transit time (OCTT) in individuals experiencing abdominal distention. Utilizing a non-invasive breath test, the study aims to correlate the severity and characteristics of abdominal distention with the presence of SIBO and OCTT irregularities. By analyzing these relationships, the research seeks to enhance the understanding of the underlying causes of abdominal distention and improve diagnostic and treatment strategies for affected patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 who primarily complain of abdominal bloating or distention.
Not a fit: Patients with gastrointestinal malignancies, recent gastrointestinal surgeries, or specific food intolerances may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnostic methods and treatment options for patients suffering from abdominal distention.
How similar studies have performed: Previous studies utilizing breath tests for diagnosing SIBO have shown promising results, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jinan, Shandong
- Gastroenterology Department of Qilu Hospital — Jinan, Shandong, China (Recruiting)
Study contacts
- Principal investigator: Feixue Chen, MD — Qilu Hospital of Shandong University
- Study coordinator: Xiuli Zuo, MD,PhD
- Email: zuoxiuli@sdu.edu.cn
- Phone: 15588818685
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.