T2DM probiotic intervention clinical data

The University of Sydney

Dataset description

Dataset contains IPD for 60 participants, all demographic and clinical data variables collected at baseline, week 6 and week 12
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Source Study




Phase 1


Commercial sector/Industry,Medlab Clinical Ltd

Scientific enquiries

Prof Luis Vitetta

Brief Summary

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. We hypothesize that the administration of an evidence based probiotic preparation may modulate the GI microbiota from a dysbiotic to a balanced state improv ....
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Key Inclusion Criteria

- Overweight adults (BMI greater than or equal to 25 kg/m2) with pre-diabetes (impaired fasting glucose, IFG and/or impaired glucose tolerance, IGT) or recently diagnosed with T2DM (less than 12 months) - Treated by diet alone or diet plus metformin

Key Exclusion Criteria

- Subjects with type 1 diabetes. - Taking oral blood glucose-lowering medications or anti-obesity drugs (other than metformin) Pregnant, breast feeding or planning on becoming pregnant - Concomitant GI disorders. - Taking antibiotics and dietary supplements including fish oil, probiotics, prebiotics, multivitamins, minerals, herbal preparations etc. 4 weeks before commencing the trial and for the duration of the trial. - Alcohol abuse and the use of any illicit drug - Any psychiatric disorders b ....
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Can healthy volunteers participate?




Sample Size    60

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Insulin resistance , Obesity , Type 2 Diabetes

Condition code    Alternative and Complementary Medicine , Diet and Nutrition , Metabolic and Endocrine


Intervention code Treatment: Other

Participants will be randomised to take either a multi-strain probiotic preparation or a placebo for 12 weeks duration and will be provided with supplementation every 6 weeks. 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. The ....
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Control group Placebo

The control group will take a placebo which contains inactive ingredients that will look, smell and taste like the probiotic but without any medical benefit. Participants randomised to the control group will take 2 capsules of the placebo preparation (200 mg of microcrytalline cellulose and excipients) twice a day for 12 weeks.


Outcome: Fasting plasma glucose
Timepoint: Baseline and 12 weeks after intervention commencement

Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

IPD underlying published results only

When will data be available?

From 1st July 2023 data will be available for an indefinite time

Available to whom?

Researchers from not-for-profit organisations. All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.

Available for what types of analyses?

Any approved protocol/proposal

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see