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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074421
Recruitment Status : Not yet recruiting
First Posted : August 30, 2019
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

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 Name: 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 Name: Placebo




Primary Outcome Measures :
  1. the IBS symptom grade score [ Time Frame: 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

  2. the quality of life score [ Time Frame: baseline ]
    IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score

  3. the IBS symptom grade score [ Time Frame: 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

  4. the quality of life score [ Time Frame: 2 weeks ]
    IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score

  5. the IBS symptom grade score [ Time Frame: 12 weeks ]
    The IBS Severity Inventory (IBS-SSS) will be used to evaluate the IBS symptom grade score

  6. the quality of life score [ Time Frame: 12 weeks ]
    IBS Quality of Life Scores (QOL) will be used to evaluate the quality of life score

  7. 16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota [ Time Frame: 12 weeks ]
    16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community

  8. 16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota [ Time Frame: baseline ]
    16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community

  9. 16 S rRNA (ribosomal ribonucleic acid) to detect gut microbiota [ Time Frame: 2 weeks ]
    16 S rRNA (ribosomal ribonucleic acid) sequencing will be applied to determine the change of microbial community



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074421


Contacts
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Contact: Liangjing Wang, Ph.D +8613777848083 wangljzju@zju.edu.cn
Contact: Zhenghua Lin, Ph.D +8618858152082 floretwan@zju.edu.cn

Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: Liangjing Wang, Ph.D Second Affiliated Hospital, School of Medicine, Zhejiang University
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04074421    
Other Study ID Numbers: 研2019-248
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study is not yet recruiting and unfinished.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
Rifaximin
Probiotics
IBS-D
gut microbiota
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents