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| Name | Class |
|---|---|
| Sir Run Run Shaw Hospital | OTHER |
| The First Affiliated Hospital of Zhejiang Chinese Medical University | OTHER |
| RenJi Hospital | OTHER |
| Peking Union Medical College Hospital |
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We will use the latest Rome IV criteria to recruit IBS-D patients and evaluate the effects of repeated treatment with rifaximin and sequential treatment with rifaximin and probiotics on different symptoms and quality of life. High-throughput sequencing combined with real-time quantitative PCR will be used to comprehensively analyze the effects of different drugs on intestinal flora. The study has important guiding significance for the treatment of patients with IBS-D.
According to the Rome IV diagnostic criteria, 200 patients with with diarrhoea-predominant irritable bowel syndrome (IBS-D) from the multi-center (8 units in the country) will be enrolled. The IBS Severity Inventory (IBS-SSS) and IBS Quality of Life Scores (QOL) will be used to evaluate the effect of treatments. Retreatment patients who are initially treated and not satisfied with the improvement of symptoms and quality of life will be treated with Rifaximin for 2 weeks. Fecal specimens will be collected from patients who responded to treatment, and the fecal bacteria will be analyzed by real-time polymerase chain reaction (PCR) using 16 S ribosomal ribonucleic acid (rRNA) gene. Patients who responded to Rifaximin treatment will be randomized into A (Probiotics group) and B (Placebo group). IBS symptom grade score and quality of life score will be evaluated before and after treatment, and fecal specimens of the responding patients will be collected for intestinal probiotics and harmful bacteria detection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifaximin group | Active Comparator | Repeating treatment of Rifaximin |
|
| Probiotics group | Sham Comparator | Sequential treatment of probiotics called Bacillus subtilis and Enterococcus faecium |
|
| Placebo group | Placebo Comparator | Placebo control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug | A non-aminoglycoside intestinal antibiotic, 400mg, twice one day for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the IBS symptom grade score | The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score | baseline |
| the quality of life score | IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score | baseline |
| the IBS symptom grade score | The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score | 2 weeks |
| the quality of life score | IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score | 2 weeks |
| the IBS symptom grade score | The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score | 12 weeks |
| the quality of life score | IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score | 12 weeks |
| 16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota | 16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liangjing Wang, Ph.D | Contact | +8613777848083 | wangljzju@zju.edu.cn | |
| Zhenghua Lin, Ph.D | Contact | +8618858152082 | floretwan@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Liangjing Wang, Ph.D | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
The study is not yet recruiting and unfinished.
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| OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| The Central Hospital of Lishui City | OTHER |
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| Probiotic Formula | Drug | A probiotic called Enterococcus faecium, 500mg, triple one day for 4 weeks. |
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| Placebo oral tablet | Drug | Placebo oral tablet that has no therapeutic effect |
|
|
| 16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota | 16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community | baseline |
| 16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota | 16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community | 2 weeks |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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