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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
240
A non-aminoglycoside intestinal antibiotic, 400mg, twice one day for 2 weeks.
A probiotic called Enterococcus faecium, 500mg, triple one day for 4 weeks.
Placebo oral tablet that has no therapeutic effect
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGthe 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
Time frame: baseline
the quality of life score
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
Time frame: 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
Time frame: 2 weeks
the quality of life score
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
Time frame: 2 weeks
the IBS symptom grade score
The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score
Time frame: 12 weeks
the quality of life score
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 weeks
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