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

Gut Microbiota Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04074421
• Other study ID #: (2019) Study No. 413
• Status: Recruiting
• Phase: Phase 4
• Start date: May 10, 2020
• Est. completion date: December 2022

Study information

• Verified date: August 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Liangjing Wang, Ph.D
• Phone: +8613777848083
• Email: wangljzju[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gut Microbiota
• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Rifaximin
A non-aminoglycoside intestinal antibiotic, 400mg, twice one day for 2 weeks.
• Probiotic Formula
A probiotic called Enterococcus faecium, 500mg, triple one day for 4 weeks.
• Placebo oral tablet
Placebo oral tablet that has no therapeutic effect

Locations

Country	Name	City	State
China	The Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (7)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	First Affiliated Hospital of Wenzhou Medical University, Peking Union Medical College Hospital, RenJi Hospital, Sir Run Run Shaw Hospital, The Central Hospital of Lishui City, The First Affiliated Hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	the quality of life score	IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score	baseline
Primary	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
Primary	the quality of life score	IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score	2 weeks
Primary	the IBS symptom grade score	The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score	12 weeks
Primary	the quality of life score	IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score	12 weeks
Primary	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
Primary	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
Primary	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