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RECRUITING

NCT06772064

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

Sponsor: Xiuli Zuo

View on ClinicalTrials.gov

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.

Official title: Efficacy of Rifaximin in Patients With Small Intestinal Bacterial Overgrowth Presenting With Abdominal Bloating: An Exploratory Study.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

115

Start Date

2025-04-15

Completion Date

2025-12-01

Last Updated

2025-05-16

Healthy Volunteers

Yes

Conditions

SIBO

Interventions

DRUG

Rifaximin (drug)

Rifaximin 0.4g bid for 2 weeks

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.

Locations (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China