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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 October 2015 |
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Main ID: |
NCT02565654 |
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Date of registration:
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29/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy of Rifaximin to Treat Diarrhea-predominant Irritable Bowel Syndrome
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Scientific title:
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Efficacy of Rifaximin for Diarrhea-predominant Irritable Bowel Syndrome With Positive Lactulose Hydrogen Breath Test |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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120 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02565654 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Lishou Xiong, MD PHD |
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Address:
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Telephone:
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Email:
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xionglishou@263.net |
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Affiliation:
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Name:
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Xiaojun Zhuang, MD |
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Address:
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Telephone:
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Email:
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492348643@qq.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Irritable Bowel Syndrome
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Primary Outcome(s)
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the proportion of patients who had adequate relief of global IBS symptoms
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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the proportion of patients who with positive lactulose hydrogen breath test change to be negative
[Time Frame: 2 weeks]
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the composition of patients's fecal microbiota
[Time Frame: 2 weeks]
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Secondary ID(s)
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0717-201506
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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