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)

February 20, 2026 updated by: Istituto Nazionale di Ricovero e Cura per Anziani
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy, 60127
        • IRCCS INRCA Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: probiotic supplementation arm
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
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.
No Intervention: control arm
The control group consists of subjects on home enteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the gut microbiota composition
Time Frame: 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.
from the enrolment to the end of study at 30 days
Change in the production of SCFA
Time Frame: 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.
from the enrolment to the end of study at 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Investigators

  • Principal Investigator: Paolo Orlandoni, MD, IRCCS INRCA, Ancona, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2018

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INRCA_002_2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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