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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotic supplementation arm | Experimental | The experimental arm consists of subjects on home enteral nutrition supplemented supplemented for 30 days with probiotics (one 0.26 g capsule/day administered via probe) |
|
| control arm | No Intervention | The control group consists of subjects on home enteral nutrition |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotic supplementation | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the gut microbiota composition | 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. | from the enrolment to the end of study at 30 days |
| Change in the production of SCFA | 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. | from the enrolment to the end of study at 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Orlandoni, MD | IRCCS INRCA, Ancona, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS INRCA Hospital | Ancona | 60127 | Italy |
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|
| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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