T2DM probiotic intervention clinical data
The University of SydneyDataset description
Dataset contains IPD for 60 participants, all demographic and clinical data variables collected at baseline, week 6 and week 12Identifiers
Source Study
Trial name (public)
The Effect of a Multi-strain Probiotic on Metabolic Biomarkers in Adults with Pre-diabetes and Recently Diagnosed with Type 2 DiabetesTrial acronym
Not available
Trial ID
ACTRN12613001378718
Purpose
Treatment
Phase
Phase 1
Funding
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 .... Read more
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 .... Read more
Can healthy volunteers participate?
No
Population
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
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 .... Read more
Comparison
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.
Outcomes
Outcome: Fasting plasma glucose Timepoint: Baseline and 12 weeks after intervention commencement
Will individual participant data (IPD) for this trial be available?
yes
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