Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With IBS-D
NCT04074421 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2020-07-28
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.
Conditions
- IBS - Irritable Bowel Syndrome
- Gut Microbiota
Interventions
- DRUG
-
Rifaximin
A non-aminoglycoside intestinal antibiotic, 400mg, twice one day for 2 weeks.
- DRUG
-
Probiotic Formula
A probiotic called Enterococcus faecium, 500mg, triple one day for 4 weeks.
- DRUG
-
Placebo oral tablet
Placebo oral tablet that has no therapeutic effect
Sponsors & Collaborators
-
Sir Run Run Shaw Hospital
collaborator OTHER -
The First Affiliated Hospital of Zhejiang Chinese Medical University
collaborator OTHER -
RenJi Hospital
collaborator OTHER -
Peking Union Medical College Hospital
collaborator OTHER -
First Affiliated Hospital of Wenzhou Medical University
collaborator OTHER -
The Central Hospital of Lishui City
collaborator OTHER -
Second Affiliated Hospital, School of Medicine, Zhejiang University
lead OTHER
Principal Investigators
-
Liangjing Wang, Ph.D · Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-10
- Primary Completion
- 2022-06-30
- Completion
- 2022-12-31
Countries
- China
Study Locations
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