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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 -

SLCTR Registration Number

SLCTR/2018/004


Date of Registration

25 Jan 2018

The date of last modification

May 18, 2018



Application Summary


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


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1206-6905


Any other number(s) assigned to the trial and issuing authority

P/252/10/2017 (ERC: Kelaniya)


Trial Details


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

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy


Assignment

Parallel


Purpose

Treatment


Intervention(s) planned

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.


Inclusion criteria

  1. Male and female patients aged between 18-80 years
  2. Type 2 diabetes for more than 5 years with last HbA1c done within three months of recruitment of more than 8%

Exclusion criteria

  1. Patients with known allergies to rifaximin.
  2. Patients who have taken any antibiotic within three months prior to the recruitment.
  3. Patients who are on continuous proton pump inhibitors for more than one month duration at the time of recruitment
  4. Patients who are on concurrent vitamin supplements at the time of recruitment.
  5. Patients who have chronic lower gastro intestinal symptoms at the time of recruitment.
  6. Patients who are pregnant or lactating


Primary outcome(s)

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

None


Secondary outcome(s) - Time of assessment(s)

None



Target number/sample size

50 (25 each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2018-02-15


Anticipated end date

2018-08-15


Recruitment status

Recruiting


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)


Funding source

None (Investigator funded)



Contact & Sponsor Information


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
Mob: 0718258485
Fax: +94112958337
ranjanp64@gmail.com

Contact Person for Public Queries

Dr. M.G.S.K. Weerasinghe
Senior Registrar in Medicine
Colombo North Teaching Hospital, Ragama, Sri Lanka
Tel: +94112961000
Mob: +94783642839
Fax: +94112958337
sanjayakit@gmail.com


Primary study sponsor/organization

Faculty of Medicine, University of Kelaniya

PO Box 06, Thalagolla Road, Ragama, Sri Lanka
Tel: +94 11 2953409 / 11 2961119
Fax: +94112958337
ranjanp64@gmail.com
http://medicine.kln.ac.lk/

Secondary study sponsor (If any)

None