Efficacy of Rifaximin to Treat Diarrhea-predominant Irritable Bowel Syndrome (NCT02565654) | Clinical Trial Compass
UnknownNot Applicable
Efficacy of Rifaximin to Treat Diarrhea-predominant Irritable Bowel Syndrome
China120 participantsStarted 2015-10
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. age \<18 years;
. use of antimicrobial agents within the previous 3 months;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the proportion of patients who had adequate relief of global IBS symptoms
Timeframe: 12 weeks
Trial details
NCT IDNCT02565654
SponsorFirst Affiliated Hospital, Sun Yat-Sen University
. 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,