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Can probiotics boost gut health in Tube-Fed seniors?

NCT ID NCT07437352

Disease control Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a 30-day course of a probiotic supplement could improve the balance of gut bacteria and increase production of beneficial short-chain fatty acids in frail elderly patients who receive all their nutrition through a feeding tube at home. Twenty-seven participants were randomly assigned to receive either the probiotic or a placebo. Researchers also monitored for digestive issues like constipation and diarrhea.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
probiotic supplement (Lactobacillus rhamnosus and Lactobacillus paracasei)
What this could lead to
If it works, this could point toward a simple way to improve gut health and reduce digestive problems in frail elderly people who rely on tube feeding.
What could go wrong
This is a very small, early-stage study with only 27 participants. The results may not apply to all elderly patients, and the benefits may be modest or not statistically significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

27 people

The number who actually took part.

Started

Jun 2018

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Frailty

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Enteral nutrition

Contacts and locations

Locations

  • IRCCS INRCA Hospital

    Ancona, 60127, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.