Efficacy of Rifaximin to Treat Diarrhea-predominant Irritable Bowel Syndrome

September 30, 2015 updated by: XiaojunZhuang, First Affiliated Hospital, Sun Yat-Sen University

Efficacy of Rifaximin for Diarrhea-predominant Irritable Bowel Syndrome With Positive Lactulose Hydrogen Breath Test

Irritable bowel syndrome (IBS) is a common disease and the pathogenesis of this disease includes central and peripheral mechanisms. In recent years, there were many studies suggesting that microbiota in the intestine may play an important role in the IBS.What's more, small intestinal bacterial overgrowth (SIBO) may be an important pathogenic factor for IBS and the use of antibiotics may be beneficial. Therefore, the investigators intend to explore the efficacy of rifaximin for IBS-D in Chinese population.

Study Overview

Status

Unknown

Conditions

Detailed Description

Recent evidence suggests that a shift in the host-gut microbial relationship as seen in small intestinal bacterial overgrowth (SIBO) may contribute to the pathogenesis of IBS.Overgrowth of microbiota in the small intestine can cause excessive gas production and malabsorption with a variety of nonspecific symptoms, such as diarrhea, gas bloating, abdominal pain and constipation.Glucose (GBT) and lactulose (LBT) breath test have been proposed as simple, inexpensive and non-invasive diagnostic tools for detecting SIBO with respect to the gold standard (the culture of intestinal aspirates). Many antibiotics have been proposed in the last years for SIBO eradication.Rifaximin is a rifamycin derivative with antibacterial activity caused by inhibition of bacterial synthesis of RNA and which is effective against both gram-positive and -negative bacteria, including aerobes and anaerobes.As <0.1% of its oral dose is absorbed, rifaximin administration is associated to a very low side-effect incidence. However,there are still no effective and reliable treatment for IBS,so we intend to explore the prevalence of SIBO in IBS-D patients and evaluate the efficacy of rifaximin for IBS-D in Chinese population.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guang zhou, Guangdong, China, 510080
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaojun Zhuang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 40 cases of LHBT positive and 20 cases of LHBT negative IBS-D patients will be included in this study. The estimate of the LHBT positive rate was 40%, so we need to screen about 100 IBS-D patients. We are going to recruit 120 IBS-D patients in our center with respect to patients lost to follow up.

Description

Inclusion Criteria:

  1. aged 18-65 yr;
  2. IBS-D fulfiling the ROME III criteria;
  3. had undergone a colonoscopic examination within the previous 2 years;
  4. had received a diagnosis of and had current symptoms of IBS, in particular, symptoms of abdominal pain and discomfort; and did not have adequate relief of global IBS symptoms and of IBS-related bloating at both the time of screening and the time of randomization.

Exclusion Criteria:

  1. age <18 years;
  2. use of antimicrobial agents within the previous 3 months;
  3. known hypersensitivity to agents belonging to rifamycin and/or tetracycline families;
  4. pregnancy or breast-feeding;
  5. evidence of major concomitant diseases (including tumours and hepatic and ⁄ or renal insufficiency);
  6. not on antibiotic treatment or probiotics for at least 4 weeks prior to undergoing the LHBT;
  7. fibre supplements or laxatives 1-week prior to the LHBT test date
  8. presence of endoscopic or histological alterations, which might be indicative of other disorders (e.g. celiac disease, inflammatory bowel disease, diverticulosis or diverticulitis) and contribute to IBS symptom generation,
  9. evidence of major concomitant diseases (including tumours and hepatic and/or renal insufficiency)
  10. unstable thyroid disease
  11. bowel obstruction
  12. known lactose intolerance
  13. any evidence of advanced organic or psychiatric disease that may impact on the patient's compliance or adherence to the study protocol.
  14. use of medications known to cause constipation (eg, narcotics, antidiarrheals, alosetron)
  15. history of abdominal surgery involving the gastrointestinal tract such as appendicectomy, cholecystectomy
  16. Inability to sign or rejection to informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Rifaximin group
Patients are treated with rifaximin (Alfa Wassermann Pharmaceutical Co., Ltd. Italy) for 14 days at a daily dosage of 1200 mg (400 mg, three times daily)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the proportion of patients who had adequate relief of global IBS symptoms
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
the proportion of patients who with positive lactulose hydrogen breath test change to be negative
Time Frame: 2 weeks
2 weeks
the composition of patients's fecal microbiota
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0717-201506

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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