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Efficacy of Rifaximin to Treat Diarrhea-predominant Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT02565654
Recruitment Status : Unknown
Verified June 2015 by XiaojunZhuang, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Not yet recruiting
First Posted : October 1, 2015
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
XiaojunZhuang, First Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
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.

Condition or disease
Irritable Bowel Syndrome

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Efficacy of Rifaximin for Diarrhea-predominant Irritable Bowel Syndrome With Positive Lactulose Hydrogen Breath Test
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Rifaximin

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)



Primary Outcome Measures :
  1. the proportion of patients who had adequate relief of global IBS symptoms [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. the proportion of patients who with positive lactulose hydrogen breath test change to be negative [ Time Frame: 2 weeks ]
  2. the composition of patients's fecal microbiota [ Time Frame: 2 weeks ]

Biospecimen Retention:   Samples With DNA
Faeces


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

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): NCT02565654


Contacts
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Contact: Lishou Xiong, MD PHD xionglishou@263.net

Locations
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China, Guangdong
The first Affiliated Hospital of Sun Yat-Sen university
Guang zhou, Guangdong, China, 510080
Contact: Xiaojun Zhuang, MD       492348643@qq.com   
Contact: Lishou Xiong, MD PHD       xionglishou@263.net   
Principal Investigator: Xiaojun Zhuang, MD         
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University

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Responsible Party: XiaojunZhuang, doctor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02565654    
Other Study ID Numbers: 0717-201506
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: June 2015
Keywords provided by XiaojunZhuang, First Affiliated Hospital, Sun Yat-Sen University:
Irritable bowel syndrome(IBS)
Small intestinal bacterial overgrowth (SIBO)
Rifaximin
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Diarrhea
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents