None listed
Conditions
Brief summary
Diabetes mellitus is a looming epidemic worldwide, posing substantial burden on global health and economy. The prevalence of type 2 diabetes mellitus (T2DM) continues to increase and is expected to reach 592 million by 2035. Low grade chronic inflammation has been associated with the onset of T2DM. Probiotics, which are health promoting live microorganisms, may influence the levels of endotoxin and gut hormones thus, improving the glycaemic control in T2DM patients. Therefore, the aim of this study is to investigate the effects of probiotics on glycaemic control in T2DM patients. A total of 100 consenting adult T2DM patients will be enrolled in this study and to receive daily probiotics or placebo for 24 weeks. It is anticipated that probiotics will induce beneficial changes in gut microbiota, reduce systemic inflammatory state and increase secretion of gut hormones, leading to improved glycaemic control and quality of life in T2DM patients.
Interventions
Patients will be assigned randomly to receive a capsule of 10 billion CFU probiotic mixture twice daily (Probio-Tec Registered Trademark, Chr Hansen Holding A/S, Denmark) or placebo, for a duration of 24 weeks.
a) Composition of probiotic mixture: Bifidobacterium BB-12 Registered Trademark and
Lactobacillus rhamnosus LGG Registered Trademark (LGG Registered Trademark is a registered trademark of Valio Ltd.) (50%:50%)
b) dose of each microorganism: 1 billion CFU for each strain per capsule
c) mo
Patients will be assigned randomly to receive a capsule of 10 billion CFU probiotic mixture twice daily (Probio-Tec Registered Trademark, Chr Hansen Holding A/S, Denmark) or placebo, for a duration of 24 weeks. a) Composition of probiotic mixture: Bifidobacterium BB-12 Registered Trademark and Lactobacillus rhamnosus LGG Registered Trademark (LGG Registered Trademark is a registered trademark of Valio Ltd.) (50%:50%) b) dose of each microorganism: 1 billion CFU for each strain per capsule c) mode of administration: oral capsule Adherence assessment: Pill(capsule) counting, clinic appointment, phone interview and self-reported assessment
Sponsors
Dr. Neoh Chin Fen
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1) T2DM patients, with glycosylated hemoglobin (HbA1c) of 7% to 10% 2) No change in oral hypoglycaemic agents during the last 3 months
Exclusion criteria
1.Already on insulin or insulin analogs or maximum dose of oral hypoglycaemic agents 2.Regular intake of probiotics (including fermented dairy products), antacids, H2-receptor blockers, proton pump inhibitors, loperamide, corticosteroids or sex steroids 3.Systemic antibiotics within 1 month before inclusion 4.Active smokers (still smoking at least 1 cigarette for the past 6 months) 5.Daily alcohol consumption >30 g 6.Significant immunodeficiency 7.Liver, thyroid, kidney or cardiac valvular disorder 8.Chronic gastrointestinal disease 9.Neurological disorders (e.g. Alzheimer's disease, stroke, Parkinson disease) 10.Breast-feeding, pregnancy or plan to become pregnant in the next 6-12 months 11.Participation in another clinical trial within the last 6 months 12.Enduring mental health problems (e.g. schizophrenia, bipolar disorder) 13.Incapacity to give consent
Outcome results
None listed