T2Biotic™ (Concept Formulation)

Diabetes
ANZCTR: ACTRN12613001378718
Progress - Pre-Clinical - Completed

test

Study Site:

Level 2 W80, Charles Perkins Centre D17, The University of Sydney, NSW, 2006 Australia

Formulation:

The product contains 8 probiotic strains (3 Lactobacillus, 3 Bifidobacterium, Streptococcus thermophilus and 1 yeast (500 mg per capsule equating to 50 billion cfu). Two capsules of the probiotic/placebo will be prescribed to be taken twice a day. The probiotic has to be consumed orally with cold non-carbonated water.

About Trial:

This study assesses the effect of a multi-strain probiotic on metabolic biomarkers in adults with Pre-diabetes and recently diagnosed with Type 2 Diabetes. The aim of this study is to assess the efficacy of a probiotic preparation in improving glucose metabolism and metabolic markers in adults with pre-diabetes and recently diagnosed with T2DM. Moreover, gut permeability, faecal and metabolomic profiles will be measured to evaluate a potential mechanisms of action of the multi-strain probiotic. 

Type 2 diabetes mellitus (T2DM) is a major public health problem worldwide. It is characterised by the increased concentration of glucose in the blood and leads to damage of the body system, especially blood vessels and nerves. Lifestyle modification is often combined with anti-diabetic therapy as the standard of care for T2DM to maintain the proper blood glucose and to prevent long-term diabetic complications.

Source: Rittiphairoj, T., Pongpirul, K., Mueller, N.T. et al. (2019) Probiotics for glycemic control in patients with type 2 diabetes mellitus: protocol for a systematic review. Syst Rev 8, 227. 

Almost 1 million Australian adults (5.3% of those aged 18 and over) had type 2 diabetes in 2017–18, according to self-reported data from the Australian Bureau of Statistics (ABS) 2017–18 National Health Survey.

In 2015–16, an estimated 2.3% ($2.7 billion) of total disease expenditure in the Australian health system was attributed to diabetes (AIHW 2019b).


Source: AIHW 2019a. Australian Burden of Disease Study: impact and causes of illness and death in Australia 2015. Australian Burden of Disease series no. 19. Cat. no. BOD 22. Canberra: AIHW. Viewed 24 March 2020.

HREC Date:

2015-04-22

HREC Date:

2015-04-22

HREC ID:

X14-0369 & HREC/14/RPAH/492

PUBLICATIONS OR CONFERENCES ASSOCIATED WITH THE PROGRAM

The intestinal microbiome, metabolic diseases and probiotics

BIT 15th International Conference: IDDST. Osaka, Japan. Jul 26-28 2017

Date:          2017-07-26

Authors:   Vitetta L

The Efficacy Of A Novel Probiotic On Glucose Metabolism: A Randomised Controlled Trial.

The 4th Latin America Congress on Controversies to Consensus in Diabetes, Obesity and Hypertension Buenos Aires, Argentina. 2017 Mar 16-18

Date:          2017-03-16

Authors:   Palacios T, Caterson I, Madigan C, Vitetta L

The Effect Of Microbiota-Based Interventions And Metformin In Metabolic And Inflammatory Biomarkers In Adults With Type 2 Diabetes Mellitus (T2DM).

4th International Conference on the Science of Nutrition in Medicine and Healthcare. 2014 May 3-5, 2014. Gold Coast, Australia

Date:          2014-05-03

Authors:   Palacios T, Coulson S, Butt H, Vitetta L

Targeting the Intestinal Microbiota to Prevent Type 2 Diabetes and Enhance the Effect of Metformin on Glycaemia: A Randomised Controlled Pilot Study

https://pubmed.ncbi.nlm.nih.gov/32660025/

Date:          2020-07-09

The development of a evidence-based probiotic formulation and its efficacy in obesity and type 2 diabetes

4th Beneficial Microbes Conference, Amsterdam, The Netherlands. 9-11 October 2017

Date:          2017-10-09

Authors:   Palacios T, Vitetta L, Madigan C, Caterson I

Prediabetes and Early Diagnosed T2DM: safety tolerability and pilot exploratory study preliminary results.

5th MICROBIOME R and D and BUSINESS COLLABORATION FORUM: USA COLLABORATIONS IN MICROBIOME RESEARCH, LIVE BACTERIAL THERAPEUTICS, HUMAN HEALTH & DISEASE | 2nd PROBIOTICS CONGRESS San Diego, USA. 2-3 November 2017

Date:          2017-11-02

Authors:   Palacios T, Vitetta L, Madigan C, Caterson I


PARTNER'S ASSOCIATED WITH THE PROGRAM

Agilex Biolabs

Agilex are experts in bio analytical excellence. Medlab’s Human Analytics (ASSAY) are developed in conjunction with Agilex Biolabs Pty Ltd with ongoing commercial relationships that pay royalty to Medlab from all 3rd parties.

Aust Biotech

AusBiotech

Medlab is an active member of AusBiotech, an organisation representing the Australian life sciences industry. They network with over 3,000 members including therapeutics, medical technology (devices and diagnostics), digital health, food technology and agricultural sectors.