Enteral Nutrition
Conditions
Keywords
older people, frailty, gut microbiota, short chain fatty acid, probiotic supplementation
Brief summary
This is an investigator-initiated, spontaneous, non-profit, randomized intervention study with two parallel arms. The study aims to evaluate the effect of a 30-days probiotic supplementation on the composition of the intestinal microbiota (MA) and the production of short-chain fatty acids (SCFAs) in faecal samples of frail elderly patients receiving home enteral nutrition (HEN) with an oligomeric formula. Participants will be monitored for gastrointestinal complications like constipation and diarrhea, and for Clostridium difficile infections.
Interventions
DIETARY_SUPPLEMENTprobiotic supplementation
Subjects take 1 capsule/die of the probiotic SYNBIO® (Synbiotec Srl, Camerino, Italy). Each capsule contains 0.26 g of a 1:1 mixture of Lactobacillus rhamnosus IMC501® and Lactobacillus paracasei IMC502®, equivalent to a daily dose of 15 billion live probiotic cells. For enteral nutrition, the probiotic powder was suspended into 5-10 mL of water and administered directly through the feeding tube. The product is gluten-free, lactose-free, and contains no milk proteins.
Sponsors
Istituto Nazionale di Ricovero e Cura per Anziani
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Use of oligomeric enteral formula since at least 30-days * Absence of diagnosed intestinal inflammation (e.g., Crohn's disease or ulcerative colitis).
Exclusion criteria
* Antibiotic use within one month prior to enrolment * Intake of any probiotics other than the study product within one month prior to enrolment * Hypersensitivity to any probiotic ingredient * Non-exclusive enteral nutrition (minimal oral intake)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the gut microbiota composition | from the enrolment to the end of study at 30 days | To evaluate the impact of 30-days probiotic supplementation on gut microbiota (GM) composition in faecal samples of frail elderly patients receiving home enteral nutrition. |
| Change in the production of SCFA | from the enrolment to the end of study at 30 days | To evaluate the impact of a one-month probiotic supplementation on short-chain fatty acid (SCFA) production in faecal samples of frail elderly patients receiving home enteral nutrition. |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORPaolo Orlandoni, MD
IRCCS INRCA, Ancona, Italy
Outcome results
None listed