Evaluation of the clinical effects of supplementation with probiotic supplement Proxian® in frail elderly patients treated with enteral nutrition

INTERVENTION: A total of 32 subjects will be randomly assigned to the intervention group (16) or to controls (16). The Proxian® probiotic supplement will be administered to the intervention group for 60 days. Proxian® is a food supplement (Errekappa spa patent) containing encapsulated and gastro‐protected probiotic micro‐organisms. A Proxian® stick contains the following doses of probiotic microorganisms: Bifidobacterium lactis (DSM 23032) = 1 billion cells / dose, Lactobacillus plantarum LP01 (LMG P‐21021) = 1 billion cells / dose and Lactobacillus buchneri Lb26 (DSM 16341) tindalized, naturally rich in selenium (20 mg). Both bifido bacteria and lactobacilli (in particular Lactobacillus plantarum) have proven to be very effective in reducing intestinal permeability (22). Being Lactobacillus buchneri Lb26 naturally rich in Selenium, Proxian® also guarantees a better bio‐availability of this mineral which, together with Zinc, also contained in the Proxian® supplement, contributes to the protection of cells from oxidative stress and to the normal functioning of the immune system. The placebo (maltodextrin) will be administered to the control group for the same duration. The packaging of the two products ‐ Proxian and placebo ‐ will be identical and will be identifiable through a special code that neither the patients or caregivers responsible for the administration or researcher will know. The intervention group will be administered, through the enteral probe, 1 sachet / day of Proxian® dissolved in water. The administration will be carried out by formal and / or informal caregivers (carers and family members) who deal with the management of the patient and will be carried out 1 hour after the administration of the enteral formula. To e CONDITION: Clinical infections and inflammation in older subjects treated with home enteral nutrition ; Infections and Infestations PRIMARY OUTCOME: ; 1. The onset of infections observed by detection of clinical manifestations of infections (prevalence) and antibiotic therapy (prevalence) during the period of administration and 90 days after the enrollment (30 days after the last administration); 2. The inflammation is assessed by C Reactive Protein (CRP) values in the intervention group and in controls following the administration of products (Proxian® and placebo) and lab analyses will be performed at baseline, 45 and 90 days after the enrollment; SECONDARY OUTCOME: ; 1. Nutritional status is assessed by Body Mass Index values assessed at baseline, 45 and 90 days after the enrollment; 2. Motility is assessed by the evidence on bowel function and its variations as reported by caregivers on the occasion of each phone contact with caregivers; 3. Compliance of caregivers and their perception of the product in different stages of administration (before and after) are assessed by specific questionnaires administered at the enrollment and after 60 days of administration; INCLUSION CRITERIA: 1. Age over 65 years 2. Patient treated with HEN for at least 1 month 3. No antibiotic therapy for at least 1 month before the enrollment 4. Written informed consent; for patients with a serious cognitive impairment the informed consent signed by legal administrator 5. Availability of a caregiver (formal or informal)