Irritable Bowel SyndromeNCT02565654
Efficacy of Rifaximin to Treat Diarrhea-predominant Irritable Bowel Syndrome
An observational study of Irritable Bowel Syndrome, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 16Show fewer
- 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
- Inability to sign or rejection to informed consent
Trial locations and contacts
1 site in 1 country.
Lishou Xiong, MD PHD contact
China1 site
The first Affiliated Hospital of Sun Yat-Sen university
Guangzhou, Guangdong, 510080
Xiaojun Zhuang, MD, 492348643@qq.com
Lishou Xiong, MD PHD, xionglishou@263.net
About this study
Official title: 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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome(IBS), Small intestinal bacterial overgrowth (SIBO), Rifaximin
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients who had adequate relief of global IBS symptoms
Measured: 12 weeks
Secondary outcomes (2)
the proportion of patients who with positive lactulose hydrogen breath test change to be negative
Measured: 2 weeks
the composition of patients's fecal microbiota
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XiaojunZhuang, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565654
- Sponsor's protocol ID
- 0717-201506
- Status last verified
- Jun 2015
- First submitted
- 29 Sep 2015
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rifaximin for Diarrhea-predominant Irritable Bowel Syndrome With Positive Lactulose Hydrogen Breath Test
- ClinicalTrials.gov ID
- NCT02565654
- Acronym / sponsor ID
- 0717-201506
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome(IBS), Small intestinal bacterial overgrowth (SIBO), Rifaximin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the proportion of patients who had adequate relief of global IBS symptoms
Time frame: 12 weeks
2 secondary outcomes
the proportion of patients who with positive lactulose hydrogen breath test change to be negative
Time frame: 2 weeks
the composition of patients's fecal microbiota
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lishou Xiong, MD PHD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lishou Xiong, MD PHD (xionglishou@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of patients who had adequate relief of global IBS symptoms (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.