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

Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With Diarrhoea-predominant Irritable Bowel syndrome-a Multicentre Controlled Study

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.

Study Overview

• Status: Unknown
• Conditions: Gut Microbiota; IBS - Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Rifaximin; Drug: Probiotic Formula; Drug: Placebo oral tablet

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Liangjing Wang, Ph.D; Phone Number: +8613777848083; Email: wangljzju@zju.edu.cn
• Study Contact Backup: Name: Zhenghua Lin, Ph.D; Phone Number: +8618858152082; Email: floretwan@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • the Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Jian-an The President

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Peking Union Medical College Hospital; RenJi Hospital; Sir Run Run Shaw Hospital; The Central Hospital of Lishui City; First Affiliated Hospital of Wenzhou Medical University; The First Affiliated Hospital of Zhejiang Chinese Medical University
• Investigators: Principal Investigator: Liangjing Wang, Ph.D, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 26, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Probiotics; gut microbiota; Rifaximin; IBS-D
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Rifaximin
• Other Study ID Numbers: (2019) Study No. 413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The study is not yet recruiting and unfinished.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No