Recruiting
Not applicable
Efficacy of Rifaximin in Patients With Small Intestinal Bacterial Overgrowth Presenting With Abdominal Bloating.
Condition(s) studied
SIBO
Investigational drug(s) / intervention(s)
Rifaximin (drug)
Rifaximin (drug): Rifaximin 0.4g bid for 2 weeks
Study summary
Abdominal bloating is a common clinical symptom in the digestive system, with obscure origins and complex mechanisms. Its etiology can be attributed to organic diseases and various Functional Gastrointestinal Disorders (FGIDs). In recent years, the roles of Small Intestinal Bacterial Overgrowth (SIBO), Oral-Cecal Transit Time (OCTT), and gut microbiota dysbiosis in Functional Abdominal Bloating/Distention (FAB/D) have garnered increasing attention. Currently, there is a lack of diagnostic tests and effective treatment measures for patients with bloating. The hydrogen/methane breath test is a safe, economical, and non-invasive examination recommended for diagnosing SIBO. Rifaximin, an antibiotic that acts exclusively in the intestines, has been widely validated for its efficacy in SIBO and in patients with SIBO co-occurring with Irritable Bowel Syndrome (IBS). However, research on the role of SIBO in the production of bloating symptoms and the extent to which rifaximin treatment of SIBO alleviates symptoms in clinical bloating patients is still lacking. This study aims to investigate the efficacy of rifaximin in patients with SIBO who primarily present with bloating. Exploring clinical treatment options for bloating provides a reference for its management. Furthermore, questionnaires on psychiatric symptoms and fecal microbiota analysis for patients with bloating-type SIBO can help clarify the etiology of bloating, offering a basis for the etiological treatment of bloating patients in the next steps.
Eligibility
Healthy Group
Inclusion Criteria:
1. Age between 18 and 70 years, both genders included.
2. No special gastrointestinal discomfort such as bloating or abdominal pain, regular bowel movements, and normal stool characteristics.
3. Negative hydrogen/methane breath test.
Exclusion Criteria:
1. Pregnant or lactating women.
2. History of gastrointestinal malignancy or gastrointestinal surgery.
3. Past diagnosis or suspicion of lactose intolerance.
4. Confirmed extra-digestive system diseases such as urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's, etc.), endocrine system (diabetes, etc.).
5. Abnormalities in professional anxiety and depression symptom rating scales.
6. Use of antibiotics, probiotics within two weeks, endoscopic examination, or use of prokinetics, secretagogues, antifoaming agents, antispasmodics, opioids, antidepressants within one week.
7. Those who cannot or are unwilling to sign an informed consent form.
Patient Group:
Inclusion Criteria:
1. Age between 18 and 70 years, both genders included.
2. Chief complaints of abdominal bloating and/or distension; outpatients with abdominal bloating and/or distension more prominent than other symptoms.
3. Positive hydrogen/methane breath test.
Exclusion Criteria:
1. Pregnant or lactating women.
2. History of gastrointestinal malignancy or gastrointestinal surgery.
3. Past diagnosis or suspicion of lactose intolerance.
4. Confirmed extra-digestive system diseases such as urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's, etc.), endocrine system (diabetes, etc.).
5. Moderate to severe abnormalities in professional anxiety and depression symptom rating scales.
6. Use of antibiotics, probiotics within two weeks, endoscopic examination, or use of prokinetics, secretagogues, antifoaming agents, antispasmodics, opioids, antidepressants within one week.
7. Those who cannot or are unwilling to sign an informed consent form.
Primary outcome measure(s)
- Negative conversion rate of hydrogen and methane breath testing — Up to 1 week after hydrogen and methane breath testing
Negative conversion rate of hydrogen and methane breath testing in patients treated with rifaximin.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Qilu Hospital of Shandong University |
Jinan |
Shandong |
Recruiting |
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