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 | Completed

• 1 other identifier: INRCA_002_2026
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Enteral Nutrition

Keywords

older people; frailty; gut microbiota; short chain fatty acid; probiotic supplementation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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)

Dietary Supplement: probiotic supplementation

control arm

NO INTERVENTION

The control group consists of subjects on home enteral nutrition

Interventions

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.

probiotic supplementation arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Use of oligomeric enteral formula since at least 30-days
• Absence of diagnosed intestinal inflammation (e.g., Crohn's disease or ulcerative colitis).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead

Study Sites (1)

IRCCS INRCA Hospital

Ancona, 60127, Italy

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paolo Orlandoni, MD

  IRCCS INRCA, Ancona, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: June 21, 2018
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)