Grant number: | 23/15012-6 |
Support Opportunities: | Scholarships in Brazil - Scientific Initiation |
Start date: | March 01, 2024 |
End date: | December 31, 2024 |
Field of knowledge: | Health Sciences - Pharmacy |
Principal Investigator: | Lizziane Kretli Winkelströter Eller |
Grantee: | Barbhara Monyque Moraes Leite |
Host Institution: | Pró-Reitoria de Pesquisa e Pós-Graduação. Universidade do Oeste Paulista (UNOESTE). Presidente Prudente , SP, Brazil |
Abstract The prevalence of patients with diabetes mellitus (DM) on hemodialysis has increased significantly, and these individuals face a high risk of clinical and nutritional complications. Given this scenario, the search for effective and safe therapeutic interventions is crucial to improve the quality of life and health of these patients. Probiotic supplementation emerges as a potential strategy to promote clinical and nutritional benefits. However, scientific literature is still limited regarding the use of probiotics in hemodialysis patients with DM. Therefore, this study aims to evaluate the impact of probiotic supplementation on clinical and nutritional parameters of hemodialysis patients with DM. This is a randomized, double-blind clinical study involving 80 diabetic patients on hemodialysis. The probiotic group (n=40) will receive probiotic supplementation in capsules containing Lactobacillus acidophilus (2 x 109 CFU), Streptococcus thermophilus (2 x 109 CFU) and Bifidobacterium longum (2 x 109 CFU); and the control group (n=40) will receive placebo. The intervention will be daily for a period of 90 days, where demographic data, gastrointestinal symptoms, health-related quality of life, laboratory data, anthropometric measurements and information on participants' dietary intake will be evaluated. Comparison of categorical variables will be performed using the chi-square test or Fisher's exact test, when appropriate. For continuous variables, the Student's t test, Pearson's correlation or one-way analysis of variance (ANOVA) will be used, followed by Tukey's tests for multiple comparisons, as appropriate, where the statistical significance adopted will be 5. %. It is hoped that this study can provide important evidence to improve the therapeutic approach and quality of life of these individuals. | |
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