Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With IBS-D

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With Diarrhoea-predominant Irritable Bowel syndrome-a Multicentre Controlled Study

Conditions
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IBS - Irritable Bowel Syndrome, Gut Microbiota

Intervention / Treatment
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* Drug: Rifaximin
* Drug: Probiotic Formula
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years old; in line with the diagnostic criteria of diarrhea-type irritable bowel syndrome Roman IV； blood routine, blood biochemistry, stool examination and colonoscopy within 2 years are no problem; no intestinal warning symptoms Exclusion Criteria: suffering from severe heart, lung, liver, kidney, nervous system diseases; suffering from mental disorders caused by schizophrenia, brain organic and physical diseases; suffering from other diseases that may affect intestinal function (such as diabetes, thyroid disease); History of previous abdominal surgery (excluding history of cholecystectomy or appendectomy); pregnant or lactating women; have undergone colonoscopy in the past month or accept other bowel preparation operations; In the past 1 month, have used antibiotics, antidiarrheal agents, intestinal flora regulation, Chinese medicine and other drugs; have participated in other dietary treatments; understand communication barriers, unable to communicate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rifaximin group<br>Repeating treatment of Rifaximin | Drug: Rifaximin<br>* A non-aminoglycoside intestinal antibiotic, 400mg, twice one day for 2 weeks.<br>|
| Sham Comparator: Probiotics group<br>Sequential treatment of probiotics called Bacillus subtilis and Enterococcus faecium | Drug: Probiotic Formula<br>* A probiotic called Enterococcus faecium, 500mg, triple one day for 4 weeks.<br>* Other names: probiotic formula Bacillus subtilis and Enterococcus faecium;|
| Placebo Comparator: Placebo group<br>Placebo control group | Drug: Placebo oral tablet<br>* Placebo oral tablet that has no therapeutic effect<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rifaximin, Probiotics, IBS-D, gut microbiota