None listed
Conditions
Brief summary
The study evaluates the impact of the probiotics' use on the progression of diabetes and the glycemic control of the patients, by examining parameters of the body composition, glycemic control, immunity and gut microbiota.
Interventions
2 sachets of VSL#3 (Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, and Streptococcus thermophilus) daily, orally, for 4 months. Adherence will be monitored according to sachet number return.
Sponsors
Charikleia Stefanaki
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
12 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
- Hb1AC ranging from 5.7% to 6.4% or - Fasting plasma glucose concentrations ranging from 100 mg/dl to 125 mg/dl or - At Oral Glucose Tolerance Test within 2 hours: blood glucose ranging from 140 mg/dl to 199 mg/dl
Exclusion criteria
1. Short-bowel syndrome patients, with concurrent D-lactic acidosis. 2. Current hospitalization for any reason. 3. Co-morbid infection of any kind. 4. Co-morbid hereditary and/or acquired immune system deficiency. 5. Patients with genetic defects in insulin action, diseases of the exocrine pancreas, gestational diabetes, endocrinopathies (Cushing’s syndrome, acromegaly, glucagonoma, pheochromocytoma, somatostatinoma, aldestoronoma, hyperthyroidism), drug or chemical- induced diabetes (vacor, pentamidine, nicotinic acid, glucocorticoids, thyroid hormone, diazoxide, b-adrenergic agonists, thiazides, clozapine, protease inhibitors), or Stiffman’s syndrome. 6. Ingestion of antibiotics < 1 month, prior enrolment and/or intake of yogurts and products containing probiotics or any immune-compromising agent, whatsoever. 7. Diarrhoea, due to the probiotics administration, that lasts more than 3 days and/or causes severe dehydration, independently of its duration. 8. Current detection of HBsAg, HBcAb presence and/or established diagnosis of hepatic disorders of any nature. 9. Inability to commit to clinical trial follow-up. 10. Atopic dermatitis. 11. Epilepsy. 12. Established or possible pregnancy. 13. Presence of metal prostheses, due to orthopaedic surgery or otherwise or implanted devices such as pacemakers. 14. Established, chronic life-threatening diseases, such as neoplasias.
Outcome results
None listed