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

Primary Purpose

IBS - Irritable Bowel Syndrome, Gut Microbiota

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Rifaximin
Probiotic Formula
Placebo oral tablet
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IBS - Irritable Bowel Syndrome focused on measuring Rifaximin, Probiotics, IBS-D, gut microbiota

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Placebo Comparator

Arm Label

Rifaximin group

Probiotics group

Placebo group

Arm Description

Repeating treatment of Rifaximin

Sequential treatment of probiotics called Bacillus subtilis and Enterococcus faecium

Placebo control group

Outcomes

Primary Outcome Measures

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
the quality of life score
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
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
the quality of life score
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
the IBS symptom grade score
The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score
the quality of life score
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
16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community
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
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

Secondary Outcome Measures

Full Information

First Posted
August 26, 2019
Last Updated
July 26, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Sir Run Run Shaw Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, RenJi Hospital, Peking Union Medical College Hospital, First Affiliated Hospital of Wenzhou Medical University, The Central Hospital of Lishui City
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1. Study Identification

Unique Protocol Identification Number
NCT04074421
Brief Title
Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With IBS-D
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2020 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Sir Run Run Shaw Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, RenJi Hospital, Peking Union Medical College Hospital, First Affiliated Hospital of Wenzhou Medical University, The Central Hospital of Lishui City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome, Gut Microbiota
Keywords
Rifaximin, Probiotics, IBS-D, gut microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rifaximin group
Arm Type
Active Comparator
Arm Description
Repeating treatment of Rifaximin
Arm Title
Probiotics group
Arm Type
Sham Comparator
Arm Description
Sequential treatment of probiotics called Bacillus subtilis and Enterococcus faecium
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo control group
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Intervention Description
A non-aminoglycoside intestinal antibiotic, 400mg, twice one day for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Probiotic Formula
Other Intervention Name(s)
probiotic formula Bacillus subtilis and Enterococcus faecium
Intervention Description
A probiotic called Enterococcus faecium, 500mg, triple one day for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Other Intervention Name(s)
Placebo
Intervention Description
Placebo oral tablet that has no therapeutic effect
Primary Outcome Measure Information:
Title
the IBS symptom grade score
Description
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
Time Frame
baseline
Title
the quality of life score
Description
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
Time Frame
baseline
Title
the IBS symptom grade score
Description
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
Time Frame
2 weeks
Title
the quality of life score
Description
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
Time Frame
2 weeks
Title
the IBS symptom grade score
Description
The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score
Time Frame
12 weeks
Title
the quality of life score
Description
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
Time Frame
12 weeks
Title
16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota
Description
16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community
Time Frame
12 weeks
Title
16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota
Description
16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community
Time Frame
baseline
Title
16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota
Description
16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liangjing Wang, Ph.D
Phone
+8613777848083
Email
wangljzju@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenghua Lin, Ph.D
Phone
+8618858152082
Email
floretwan@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liangjing Wang, Ph.D
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian-an The President

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The study is not yet recruiting and unfinished.

Learn more about this trial

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

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