Efficacy of Rifaximin to Treat Diarrhea-predominant Irritable Bowel Syndrome

NCT02565654 | Unknown DMC

• 1 other identifier: 0717-201506
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndrome(IBS); Small intestinal bacterial overgrowth (SIBO); Rifaximin

Outcome Measures

Primary Outcomes (1)

• the proportion of patients who had adequate relief of global IBS symptoms

  12 weeks

Secondary Outcomes (2)

• the proportion of patients who with positive lactulose hydrogen breath test change to be negative

  2 weeks

• the composition of patients's fecal microbiota

  2 weeks

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• aged 18-65 yr;
• IBS-D fulfiling the ROME III criteria;
• had undergone a colonoscopic examination within the previous 2 years;
• 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.

You may not qualify if:

• age \<18 years;
• use of antimicrobial agents within the previous 3 months;
• known hypersensitivity to agents belonging to rifamycin and/or tetracycline families;
• pregnancy or breast-feeding;
• evidence of major concomitant diseases (including tumours and hepatic and ⁄ or renal insufficiency);
• not on antibiotic treatment or probiotics for at least 4 weeks prior to undergoing the LHBT;
• fibre supplements or laxatives 1-week prior to the LHBT test date
• 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,
• evidence of major concomitant diseases (including tumours and hepatic and/or renal insufficiency)
• unstable thyroid disease
• bowel obstruction
• known lactose intolerance
• any evidence of advanced organic or psychiatric disease that may impact on the patient's compliance or adherence to the study protocol.
• use of medications known to cause constipation (eg, narcotics, antidiarrheals, alosetron)
• history of abdominal surgery involving the gastrointestinal tract such as appendicectomy, cholecystectomy

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The first Affiliated Hospital of Sun Yat-Sen university

Guangzhou, Guangdong, 510080, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Faeces

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Lishou Xiong, MD PHD

CONTACT

xionglishou@263.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 1, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 1, 2015

Record last verified: 2015-06

Locations

CN (1)