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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.
The study enrolled subjects who primarily complained of abdominal bloating, and underwent breath testing, along with healthy volunteers. Study participants were required to meet the inclusion criteria, not meet the exclusion criteria, and sign an informed consent form. After enrollment, they completed a case report form. Basic demographic information of the study participants, results of routine laboratory tests, clinical characteristics related to symptoms, results and values of breath test, and other data were recorded. Patients were required to provide stool samples and conduct psychiatric questionnaire scoring, and the healthy control group was also required to provide stool samples. After enrollment, patients took rifaximin dry suspension at a dosage of 0.4 g twice a day for two weeks, recording medication intake and adverse reactions through a diary card during the medication period. Two weeks after the end of the medication, the diary cards and medication packaging were collected, and the case report forms were supplemented. Stool samples were taken again, and anxiety and depression scale scores were recorded to document changes in clinical symptoms. One month after the end of the medication, patients were required to undergo a repeat breath test, and follow-ups for changes in abdominal bloating symptoms were conducted three and six months after the end of the medication .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy group | No Intervention | The healthy group met the inclusion and exclusion criteria, and stool samples were retained for microflora analysis as control. | |
| Patient group | Experimental | Patients were required to collect stool samples and score a psychopsychological questionnaire. After enrollment, patients were given Rifaximin dry suspension 0.4g bid for 2 weeks. During the medication period, patients' drug consumption and adverse reactions were recorded through diary cards. After 2 weeks of medication, diary cards and outer packaging of drugs were collected, and case report forms were supplemented. Stool samples were collected again, anxiety and depression scale scores were performed, and clinical symptom changes were recorded. The breath test was reviewed 1 month after the end of the medication, and follow-up was conducted 3 months and 6 months after the end of the medication. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin (drug) | Drug | Rifaximin 0.4g bid for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Negative conversion rate of hydrogen and methane breath testing | Negative conversion rate of hydrogen and methane breath testing in patients treated with rifaximin. | Up to 1 week after hydrogen and methane breath testing |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom remission rate | Symptom remission rate in patients treated with rifaximin | During the administration period, 1 month after the end of the administration, 3 months and 6 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of fecal flora (16 S Sequence Analysis). | Changes of fecal flora before and after rifaximin administration. | Immediately collect fecal before and after taking rifaximin. |
| The difference of fecal flora between patients and normal population (16 S Sequence Analysis). |
Healthy Group
Inclusion Criteria:
Exclusion Criteria:
Patient Group:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiuli Zuo, MD,PhD | Contact | 15588818685 | zuoxiuli@sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Test immediately after collection of stool sample. |
| Psychopsychological questionnaire score | Self-rating depression scale (SDS): minimum value: 20; maximum value:100;The dividing line between normal and anxious patients is 50 points, with higher scores indicating more severe anxiety. Self-Rating Anxiety Scale (SAS): minimum value: 20; maximum value:100; In the Chinese population, the dividing line between normal and depressed people is 53 points, with higher scores indicating more severe depression. Hamilton Anxiety Scale (HAMA):minimum value: 0; maximum value:56; The dividing line between normal and anxious patients is 7 points, with higher scores indicating more severe anxiety. Hamilton Depression Scale (HAMD): minimum value: 0; maximum value: 96; the dividing line between normal and depressed people is 8 points, with higher scores indicating more severe depression. | Collect the questionnaire and rate it immediately. |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |