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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04074421 on ClinicalTrials.gov