Actively Recruiting
Efficacy of Rifaximin in Patients With Small Intestinal Bacterial Overgrowth Presenting With Abdominal Bloating: An Exploratory Study.
Led by Xiuli Zuo · Updated on 2025-05-16
115
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Abdominal bloating is a common digestive symptom with unclear causes and complex mechanisms, often linked to both organic diseases and Functional Gastrointestinal Disorders (FGIDs). Recent attention has focused on Small Intestinal Bacterial Overgrowth (SIBO), Oral-Cecal Transit Time (OCTT), and gut microbiota imbalance as factors in Functional Abdominal Bloating/Distention (FAB/D). There is currently a lack of effective diagnostic tests and treatments for bloating, and this study aims to explore the effects of the antibiotic rifaximin on patients with SIBO who mainly experience bloating symptoms. The study also investigates psychiatric symptoms and gut microbiota to better understand bloating's causes and inform future treatments. Participants included patients with abdominal bloating and healthy volunteers. Patients receive rifaximin 0.4 g twice daily for two weeks. During treatment, medication intake and any side effects are recorded. Stool samples and psychiatric questionnaires are collected before and after treatment. One month after treatment, patients undergo a repeat breath test for hydrogen and methane, with additional symptom follow-ups at three and six months. Healthy volunteers provide stool samples for comparison but receive no intervention. Throughout the study, demographic data, clinical symptoms, laboratory test results, and breath test values are recorded. Psychiatric assessments for anxiety and depression are performed alongside stool microbiota analysis. Medication adherence and adverse reactions are tracked via diary cards. The main outcome is the rate of negative hydrogen and methane breath tests up to one week after treatment. Secondary outcomes include symptom remission rates during treatment and follow-ups. The total participation time includes treatment, testing, and follow-ups extending six months beyond treatment.
CONDITIONS
Brief Title
Efficacy of Rifaximin in Patients With Small Intestinal Bacterial Overgrowth Presenting With Abdominal Bloating.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, both genders included.
- For healthy group: no gastrointestinal discomfort such as bloating or abdominal pain, regular bowel movements, normal stool.
- For healthy group: negative hydrogen/methane breath test.
- For patient group: chief complaint of abdominal bloating and/or distension, with these symptoms more prominent than others.
- For patient group: positive hydrogen/methane breath test.
- Signed informed consent form.
You will not qualify if you...
- Pregnant or lactating women.
- History of gastrointestinal malignancy or gastrointestinal surgery.
- Past diagnosis or suspicion of lactose intolerance.
- Confirmed diseases outside the digestive system including chronic kidney disease, scleroderma, Parkinson's disease, diabetes.
- Abnormal anxiety and depression symptom scores (moderate to severe for patients).
- Use of antibiotics or probiotics within two weeks before the study.
- Use of prokinetics, secretagogues, antifoaming agents, antispasmodics, opioids, or antidepressants within one week before the study.
- Undergoing endoscopic examination within one week before the study.
- Unable or unwilling to sign an informed consent form.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Patients take rifaximin dry suspension at a dosage of 0.4 g twice a day for two weeks while recording medication intake and any adverse reactions in a diary card.
Daily medication with diary card; 1 visit to collect diary cards and medication packaging after treatment
Duration - 6 months
Two weeks after treatment, stool samples are collected again, anxiety and depression scale scores are recorded, and clinical symptom changes are documented. One month after treatment, participants undergo a repeat breath test. Additional follow-ups occur three and six months after treatment to monitor changes in abdominal bloating symptoms.
1 visit at 2 weeks post-treatment, 1 visit at 1 month post-treatment, and follow-up visits at 3 and 6 months post-treatment
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
X
Xiuli Zuo, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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