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. (MICROBIOTA)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Completed

Conditions: Enteral Nutrition

Treatments: Dietary Supplement: probiotic supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT07437352

INRCA_002_2026

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

probiotic supplementation arm

Experimental group

Description:

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)

Treatment:

Dietary Supplement: probiotic supplementation

control arm

No Intervention group

Description:

The control group consists of subjects on home enteral nutrition