SLCTR Registration Number
Date of Registration
The date of last modification
May 18, 2018
Scientific Title of Trial
Randomized Controlled Trial to assess effect of an additional short course of rifaximin compared to standard therapy alone for glycaemic control among poorly controlled diabetics
Public Title of Trial
Study to assess the role of rifaximin in glycaemic control of poorly controlled diabetics.
Disease of Health Condition(s) Studied
Type 2 Diabetes Mellitus
Universal Trial Number
Any other number(s) assigned to the trial and issuing authority
P/252/10/2017 (ERC: Kelaniya)
What is the research question being addressed?
Does a short course of rifaximin improve glycaemic control compared to standard therapy in patients with poorly controlled type 2 diabetes?
Type of study
Randomized controlled trial
Masking not used
Study setting: Professorial Medical Unit, North Colombo Teaching Hospital, Ragama.
Participants will be requested to attend on an allocated day prior to lunch after due medications. They will be requested to bring a sample of stool in a provided stool culture bottle to be handed over. Stool samples will be stored at – 80 0 C for analysis by RNA sequencing of gut microbiota on a later date as the second phase of the study.
Participants will be randomized to intervention arm and control arm using simple randomization.Each patient will be subjected to a series of capillary glucose testing (prior to lunch, 1/2hr, 1 hour, and 2 hours after a standard lunch) and recorded as baseline values.
Intervention arm: patients will receive oral rifaximin 400 mg to be taken three times daily for two weeks along with standard of care.
Control arm: patients will receive standard management only.
Both groups will be subjected to standard diabetic management according to 2017 American Diabetic Association (ADA) guidelines. Advice regarding importance of drug compliance and diet control will be given to both groups.
At the end of two weeks and four weeks all participants will be requested to bring a stool sample which will be stored in – 80 0 C for future analysis. They will be subjected to the same series of capillary glucose testing after the same diet that was given during the previous occasion.
After three months, HbA1c will be performed in all the patients. If a significant difference in glycaemic control (either >1% reduction in HbA1c level or >10% reduction in PPBS in the rifaximin arm compared to control arm) at the end of statistical analysis is observed, the second phase of the study will be conducted.
Phase 2 All the patients registered in the first phase of the study will be registered for the second phase with their consent. In the second phase, stored stool samples will be analyzed using RNA sequencing technique to see the composition of gut microbiota identify correlates of the the difference in glycaemic control and restoration of gut microbiota.
Glycaemic control assessed by reduction in HbA1c value >1% and/or reduction in post-prandial blood glucose (PPBG) >10% from baseline
Primary outcome(s) - Time of assessment(s)
HbA1C: At baseline and at the end of three months after the commencement of the intervention
PPBG: At baseline, and at the end of two weeks and four weeks after the commencement of the intervention
Secondary outcome(s) - Time of assessment(s)
Target number/sample size
50 (25 each arm)
Countries of recruitment
Anticipated start date
Anticipated end date
State of ethics review approval
Approved by the Ethics Review Committee, Faculty of Medicine, University of Kelaniya on 22nd November 2017 (Ref: P/252/10/2017)
None (Investigator funded)
Contact person for Scientific Queries/Principal Investigator
Prof. B.A.H. Ranjan Premaratne
Professor in Medicine
Faculty of Medicine, University of Kelaniya PO Box 06, Thalagolla Road, Ragama, Sri Lanka
Tel: +94 11 2953409 / 11 2961119
Contact Person for Public Queries
Dr. M.G.S.K. Weerasinghe
Senior Registrar in Medicine
Colombo North Teaching Hospital, Ragama, Sri Lanka