Gut Microbiota Clinical Trial
Official title:
Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With Diarrhoea-predominant Irritable Bowel syndrome-a Multicentre Controlled Study
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | December 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University | First Affiliated Hospital of Wenzhou Medical University, Peking Union Medical College Hospital, RenJi Hospital, Sir Run Run Shaw Hospital, The Central Hospital of Lishui City, The First Affiliated Hospital of Zhejiang Chinese Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | the quality of life score | IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score | baseline | |
Primary | 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 | |
Primary | the quality of life score | IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score | 2 weeks | |
Primary | the IBS symptom grade score | The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score | 12 weeks | |
Primary | the quality of life score | IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score | 12 weeks | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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