ABSTRACT
BACKGROUND: Lactobacillus coryniformis K8 CECT5711 has immune-modulating properties, enhances the immune response to viral antigens leading to the production of specific antibodies, and has anti-inflammatory activity, which may help to prevent uncontrolled inflammatory processes leading to respiratory and other organ failures. OBJECTIVE: The purpose of this study is to evaluate the effect of the consumption of a probiotic strain on the incidence and severity of COVID-19 in health personnel who carry out their professional work among patients with infection or suspected infection by SARS-CoV-2. METHODS: This is a double-blind randomized clinical trial in which the experimental group will receive a capsule of L coryniformis K8 per day (3×109 colony former units/day), and the control group will receive a daily placebo capsule consisting of maltodextrin. A sample size of 314 volunteers was calculated. Volunteers must meet the following inclusion criteria: older than 20 years and active health personnel caring for patients with COVID-19, including all professionals such as medical doctors, nurses, and caretakers at the 2 referral hospitals that treat patients with COVID-19. The main outcome of the clinical trial will be the incidence of symptomatic infection by SARS-CoV-2 in personnel who care for patients with suspected or confirmed COVID-19. RESULTS: The study had to be extended to the 2 referral hospitals that treat patients with COVID-19 in the province of Granada (Andalusia, Spain); Hospital San Cecilio and Hospital Virgen de las Nieves. A total of 255 individuals met the inclusion criteria and were randomly assigned to one of the 2 groups. CONCLUSIONS: The results of this randomized controlled trial will provide valuable information regarding the administration of L coryniformis K8 against COVID-19, including whether there are fewer infectious processes due to this virus or, in case of occurrence, whether the disease is milder in participants taking the probiotic strain. TRIAL REGISTRATION: ClinicalTrials.gov NCT04366180; http://www.clinicaltrials.gov/ct2/show/NCT04366180. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/37857.
ABSTRACT
INTRODUCTION: Although current recommendations suggest the use of specific formulas in enteral nutrition in people with diabetes, there is little evidence of their long-term effectiveness in glycemic control. The main objective of this study is to evaluate the long-term efficacy (24 weeks) of a specific high-protein hypercaloric enteral nutrition formula for people with diabetes in glycemic control and in their improvement in nutritional status. METHODOLOGY: This was a multicenter, prospective, observational, real-life study of patients with long-term enteral nutrition prescription through gastrostomy or nasogastric tube who received a high protein hypercaloric formula specific for diabetes. Once the participant's informed consent was obtained and the inclusion and exclusion criteria were verified, data relating to glycemic control, inflammation parameters, biochemical data, nutritional status and gastrointestinal tolerance at 0, 12 and 24 weeks were collected. RESULTS: 112 patients were recruited, 44.6% women, age 75.0 (12.0) years and a mean time of evolution of diabetes of 18.1 (9.5) years. The percentage of patients with malnutrition according to VGS decreased throughout the treatment from 78.6% to 29.9% (pâ¯<â¯0.001). Glycemic and HbA1c levels were significantly reduced at 12 and 24 weeks (Blood glucose 155.9-139.0-133.9â¯mg/dl, pâ¯<â¯0.001; HbA1c 7.7-7.3-7.1%, pâ¯<â¯0.001) while no significant changes were observed in cholesterol, triglycerides, creatinine, or glomerular filtration. A significant increase in variables related to nutritional status was observed: weight, the BMI, albumin, prealbumin and transferrin, and CRP levels were significantly reduced and the CRP/Albumin ratio decreased. Gastrointestinal tolerance was good, the number of patients with moderate-severe symptoms was small, and did not change throughout the follow-up. CONCLUSION: Our real-life study suggests that the use of a specific hyperprotein hypercaloric formula for diabetes during a 6-month nutritional treatment allows adequate glycemic control and nutritional evolution, with good gastrointestinal tolerance.
Subject(s)
Diabetes Mellitus , Nutritional Status , Aged , Albumins , Blood Glucose/metabolism , Enteral Nutrition , Female , Glycated Hemoglobin , Humans , Male , Prospective StudiesABSTRACT
INTRODUCTION: Although current recommendations suggest the use of specific formulas in enteral nutrition in people with diabetes, there is little evidence of their long-term effectiveness in glycemic control. The main objective of this study is to evaluate the long-term efficacy (24 weeks) of a specific high-protein hypercaloric enteral nutrition formula for people with diabetes in glycemic control and in their improvement in nutritional status. METHODOLOGY: This was a multicenter, prospective, observational, real-life study of patients with long-term enteral nutrition prescription through gastrostomy or nasogastric tube who received a high protein hypercaloric formula specific for diabetes. Once the participant's informed consent was obtained and the inclusion and exclusion criteria were verified, data relating to glycemic control, inflammation parameters, biochemical data, nutritional status and gastrointestinal tolerance at 0, 12 and 24 weeks were collected. RESULTS: 112 patients were recruited, 44.6% women, age 75.0 (12.0) years and a mean time of evolution of diabetes of 18.1 (9.5) years. The percentage of patients with malnutrition according to VGS decreased throughout the treatment from 78.6% to 29.9% (P<.001). Glycemic and HbA1c levels were significantly reduced at 12 and 24 weeks (Blood glucose 155.9-139.0-133.9mg/dl, P<.001; HbA1c 7.7-7.3-7.1%, P<.001) while no significant changes were observed in cholesterol, triglycerides, creatinine, or glomerular filtration. A significant increase in variables related to nutritional status was observed: weight, the BMI, albumin, prealbumin and transferrin, and CRP levels were significantly reduced and the CRP / Albumin ratio decreased. Gastrointestinal tolerance was good, the number of patients with moderate-severe symptoms was small, and did not change throughout the follow-up. CONCLUSION: Our real-life study suggests that the use of a specific hyperprotein hypercaloric formula for diabetes during a 6-month nutritional treatment allows adequate glycemic control and nutritional evolution, with good gastrointestinal tolerance.
