Changes in Microbiota and Metabolomic Profile Between Rifaximin Responders and Non-responders In Diarrhoea-Predominant Irritable Bowel Syndrome
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|ClinicalTrials.gov Identifier: NCT03557788|
Recruitment Status : Unknown
Verified May 2018 by National University Hospital, Singapore.
Recruitment status was: Recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome With Diarrhea||Drug: Rifaximin Oral Tablet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Changes in Microbiota and Metabolomic Profile Between Rifaximin Responders and Non-responders In Diarrhoea-Predominant Irritable Bowel Syndrome|
|Actual Study Start Date :||May 7, 2018|
|Estimated Primary Completion Date :||May 7, 2019|
|Estimated Study Completion Date :||May 7, 2019|
Patients who receive PO Rifaximin 500mg TDS for 2 weeks. All patients will receive treatment to evaluate the effect of the intervention. This is a single-arm study.
Drug: Rifaximin Oral Tablet
PO 550mg TDS for 2 weeks
- Change from baseline in IBS-SSS questionnaire [ Time Frame: Start of Rifaximin treatment (Visit 2, which is 1 week after first/screening visit), End of Rifaximin treatment (Visit 3, which is 2 weeks after Visit 2), and 3 months after end of treatment (Visit 4) ]Severity of IBS-D will be measured using IBS-SSS questionnaire, at baseline (visit 2) and at completion of 2 week course of Rifaximin (Visit 3) as well as 3 months after end of Rifaximin (Visit 4). A responder will be defined as a reduction of IBS-SSS by more than 50 points.
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): NCT03557788
|Soh Yu Sen, Alex||Recruiting|
|Contact: Alex Soh, MB BCh, MRCP, FAMS +6567724354 firstname.lastname@example.org|