Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With IBS-D
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2020
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2019
CompletedFirst Posted
Study publicly available on registry
August 30, 2019
CompletedStudy Start
First participant enrolled
May 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJuly 28, 2020
August 1, 2019
2.1 years
August 26, 2019
July 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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
the quality of life score
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
baseline
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
the quality of life score
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
2 weeks
the IBS symptom grade score
The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score
12 weeks
the quality of life score
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
12 weeks
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
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
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
Study Arms (3)
Rifaximin group
ACTIVE COMPARATORRepeating treatment of Rifaximin
Probiotics group
SHAM COMPARATORSequential treatment of probiotics called Bacillus subtilis and Enterococcus faecium
Placebo group
PLACEBO COMPARATORPlacebo control group
Interventions
A non-aminoglycoside intestinal antibiotic, 400mg, twice one day for 2 weeks.
A probiotic called Enterococcus faecium, 500mg, triple one day for 4 weeks.
Placebo oral tablet that has no therapeutic effect
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitylead
- Sir Run Run Shaw Hospitalcollaborator
- The First Affiliated Hospital of Zhejiang Chinese Medical Universitycollaborator
- RenJi Hospitalcollaborator
- Peking Union Medical College Hospitalcollaborator
- First Affiliated Hospital of Wenzhou Medical Universitycollaborator
- The Central Hospital of Lishui Citycollaborator
Study Sites (1)
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liangjing Wang, Ph.D
Second Affiliated Hospital, School of Medicine, Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2019
First Posted
August 30, 2019
Study Start
May 10, 2020
Primary Completion
June 1, 2022
Study Completion
December 1, 2022
Last Updated
July 28, 2020
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share
The study is not yet recruiting and unfinished.