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Clinical Trials in China / NCT06772064
Recruiting Not applicable

Efficacy of Rifaximin in Patients With Small Intestinal Bacterial Overgrowth Presenting With Abdominal Bloating.

NCT06772064 · tracked via the Priya Life Science China tracker
Sponsor
Xiuli Zuo
Phase
Not applicable
Started
2025-04-15
Last updated
2025-05-16

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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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)

FacilityCityRegionStatus
Qilu Hospital of Shandong University Jinan Shandong Recruiting

More Xiuli Zuo trials in China

Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extremely Refractory Helicobacter Pylori Infection: an Exploratory Study Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06772064 on ClinicalTrials.gov ↗ ← All trials in China