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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04074421

Collaborator

Sir Run Run Shaw Hospital (Other), The First Affiliated Hospital of Zhejiang Chinese Medical University (Other), RenJi Hospital (Other), Peking Union Medical College Hospital (Other), First Affiliated Hospital of Wenzhou Medical University (Other), The Central Hospital of Lishui City (Other)

240

Enrollment

Location

Arms

30.7

Anticipated Duration (Months)

7.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
IBS - Irritable Bowel Syndrome Gut Microbiota	Drug: Rifaximin Drug: Probiotic Formula Drug: Placebo oral tablet	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 10, 2020

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rifaximin group Repeating treatment of Rifaximin	Drug: Rifaximin A non-aminoglycoside intestinal antibiotic, 400mg, twice one day for 2 weeks.
Sham Comparator: Probiotics group Sequential treatment of probiotics called Bacillus subtilis and Enterococcus faecium	Drug: Probiotic Formula A probiotic called Enterococcus faecium, 500mg, triple one day for 4 weeks. Other Names: probiotic formula Bacillus subtilis and Enterococcus faecium
Placebo Comparator: Placebo group Placebo control group	Drug: Placebo oral tablet Placebo oral tablet that has no therapeutic effect Other Names: Placebo

Arm

Intervention/Treatment

Active Comparator: Rifaximin group

Repeating treatment of Rifaximin

Drug: Rifaximin

A non-aminoglycoside intestinal antibiotic, 400mg, twice one day for 2 weeks.

Sham Comparator: Probiotics group

Sequential treatment of probiotics called Bacillus subtilis and Enterococcus faecium

Drug: Probiotic Formula

A probiotic called Enterococcus faecium, 500mg, triple one day for 4 weeks.

Other Names:

probiotic formula Bacillus subtilis and Enterococcus faecium

Placebo Comparator: Placebo group

Placebo control group

Drug: Placebo oral tablet

Placebo oral tablet that has no therapeutic effect

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

the IBS symptom grade score [baseline]
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 [baseline]
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
the IBS symptom grade score [2 weeks]
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 [2 weeks]
IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score
the IBS symptom grade score [12 weeks]
The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score
the quality of life score [12 weeks]
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 [12 weeks]
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 [baseline]
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 [2 weeks]
16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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