Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With IBS-D
- Conditions
- Gut MicrobiotaIBS - Irritable Bowel Syndrome
- Interventions
- Registration Number
- NCT04074421
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 240
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probiotics group Probiotic Formula Sequential treatment of probiotics called Bacillus subtilis and Enterococcus faecium Placebo group Placebo oral tablet Placebo control group Rifaximin group Rifaximin Repeating treatment of Rifaximin
- Primary Outcome Measures
Name Time Method the IBS symptom grade score 12 weeks The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score
the quality of life score 12 weeks IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota 2 weeks 16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Second Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China