Effect of Rifaximin on Abdominal Bloating in SIBO Patients

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

This study is testing if the antibiotic rifaximin can help people with Small Intestinal Bacterial Overgrowth (SIBO) feel better by reducing their abdominal bloating.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 115 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shandong University (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06772064 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy of rifaximin, an antibiotic, in treating patients with Small Intestinal Bacterial Overgrowth (SIBO) who experience abdominal bloating. Participants will undergo breath testing to diagnose SIBO and will be treated with rifaximin for two weeks while documenting their symptoms and any adverse reactions. Follow-up assessments will include repeat breath tests and symptom evaluations at one, three, and six months post-treatment. The study aims to better understand the relationship between SIBO and bloating symptoms and the effectiveness of rifaximin in alleviating these symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 who have been diagnosed with SIBO and experience abdominal bloating.

Not a fit: Patients with gastrointestinal malignancies, recent gastrointestinal surgeries, or other serious systemic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce abdominal bloating symptoms in patients with SIBO, improving their quality of life.

How similar studies have performed: Previous studies have shown that rifaximin is effective in treating SIBO, suggesting potential success for this approach in alleviating bloating symptoms.

Eligibility criteria

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.

Where this trial is running

Jinan, Shandong

• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Xiuli Zuo, MD,PhD

Conditions SIBO; Abdominal bloating; Rifaximin