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Assessment of the Effects of Probiotic Supplementation on Gut Microbiota Composition and Short-chain Fatty Acid Production in Frail Elderly Patients Receiving Home Enteral Nutrition With an Oligomeric Formula.

NCT07437352 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Enteral Nutrition

Interventions

DIETARY_SUPPLEMENT

probiotic 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 & Collaborators

  • Istituto Nazionale di Ricovero e Cura per Anziani

    lead OTHER

Principal Investigators

  • Paolo Orlandoni, MD · IRCCS INRCA, Ancona, Italy

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-21
Primary Completion
2024-06-30
Completion
2024-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07437352 on ClinicalTrials.gov